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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

24 Study Matches

MT2019-06: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

The purpose of this study is to evaluate the safety and ability of a transplant with your own gene modified stem cells (autologous stem cell transplant) to treat sickle cell disease. The goal is to determine if a sufficient amount of hemoglobin that prevents red blood sickling can be produced after the gene modified stem cells are returned to your body. This study may provide information on the potential usefulness of bb1111 for treatment of sickle cell disease

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
STUDY00006923
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Inclusion Criteria:

• must be 2 to 50 years old
• diagnosis of Sickle Cell Disease
• weigh a minimum of 6 kg (13.2 pounds)
• treated and followed for at least the past 24 months
• experienced at least 4 protocol-defined VOEs in the past 24 months
• experienced HU failure at any point in the past or must have intolerance to HU
• female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from starting the study to at least 6 months after drug product infusion.
Exclusion Criteria:

• if allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available
• unable to receive a transfusion
• prior allogeneic transplant or gene therapy
• prior or current malignancy or immunodeficiency disorder, except cured tumors such as squamous cell carcinoma of the skin
• women who are pregnant or breast feeding
• additional exclusion criteria (study staff will review)
Blood Disorders
SCD, Sickle Cell Disease
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MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021552
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Inclusion Criteria:

• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Cancer
blood cancer, hematopoietic stem cell transplantation (HSCT)
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RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)

We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.

Joanne Billings
Not specified
This study is NOT accepting healthy volunteers
1702M07621
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Inclusion Criteria:

• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
Exclusion Criteria:

• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), CF, Cystic Fibrosis
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MT2021-01: PTCy + Sirolimus/VIC-1911 as GVHD prophylaxis in myeloablative PBSC transplantation

The primary objective of this study is to determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.

Punita Grover
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015049
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Inclusion Criteria:

• acute leukemia in complete remission, myelodysplasia, myeloproliferative neoplasm/myelofibrosis, or chemosensitive Hodgkin or non-Hodgkin lymphoma
• able to tolerate oral medication
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, Lymphoma, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
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MT2021-29: Evaluation of intravenous laronidase pharmacokinetics before and after hematopoietic cell transplantation in patients with mucopolysaccharidosis type IH

In this study, the researchers are collecting blood samples to learn more about laronidase treatment in children that receive a hematopoietic cell transplantation. The laronidase dose regimens used after a hematopoietic cell transplantation may differ from those administered before. This study will establish the basis for determining if there is a need to adjust laronidase dosing regimens after receiving a hematopoietic cell transplantation.

Silvia Illamola
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00016560
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Inclusion Criteria:

• between 0 to 3 years of age
• meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
• planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course
Exclusion Criteria:

• patient's parent/ legal guardians are unable to provide informed consent.
Rare Diseases, Cancer
Hematopoietic Cell Transplantation
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MT2023-31: A multi-center, randomized, active controlled clinical trial to evaluate the efficacy and safety of OTL-203 in subjects with mucopolysaccharidosis type I, Hurler syndrome (MPS-IH) compared to standard of care with allogeneic hematopoietic stem cell transplantation (allo-HSCT) (HURCULES)

This research study is designed to compare a new gene therapy, known as OTL-203 (study drug), with a standard treatment called “allogeneic hematopoietic stem cell transplant” (allo-HSCT), to find out which is better for the treatment of MPS-IH.

Ashish Gupta
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00020015
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Inclusion Criteria:

• at least 28 days old to no more than 30 months old
• confirmed laboratory diagnosis of MPS-IH
• evidence of altered GAG metabolism
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous allo-HSCT or gene therapy
• diagnosis of HIV, Hepatitis B, Hepatitis C, or Mycoplasma
• history of uncontrolled seizures
• contraindications for MRI scans
• study staff will review additional exclusion criteria
Rare Diseases
Hurler syndrome, MPS-IH, mucopolysaccharidosis type I
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MT2012-11C: Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Troy Lund
Not specified
This study is NOT accepting healthy volunteers
1207M17641
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Inclusion Criteria:

• up to 55 years old
• diagnosis of any disease for which a second or greater hematopoietic stem cell transplant (HSCT) is needed
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active, uncontrolled infection
• HIV positive
Blood Disorders
Hematologic Disorders, Hemoglobinopathies, HSCT, Immunodeficiencies, Stem Cell Transplant
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MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies

The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.

Jeffrey Miller, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00021493
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Inclusion Criteria:

• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
Cancer
Clinics and Surgery Center (CSC), cell therapy, gene therapy, HCT, Hematopoietic Cell Transplant, immunotherapy
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MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

The primary purpose of this study is to confirm the findings of our previous allogeneic hematopoietic stem cell transplant trial for non-malignant hematologic disorders that are transfusion dependent or represent other potentially life-threatening cytopenias. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
1407M52125
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Inclusion Criteria:

• up to 55 years old
• diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
• suitable stem cell donor has been identified
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active, uncontrolled infection
• women who are pregnant or breastfeeding
• HIV positive
Blood Disorders
Clinics and Surgery Center (CSC), Diamond Blackfan Anemia, Paroxysmal Nocturnal Hemoglobinuria, Sickle Cell Disease, Thalassemia
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MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
1207M17321
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Inclusion Criteria:

• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Immune Diseases, Rare Diseases
Clinics and Surgery Center (CSC), Allogeneic Hematopoietic Stem Cell Transplant, Primary Immune Deficiencies
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MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.

Samuel Goldfarb
Up to 24 years old
This study is NOT accepting healthy volunteers
SITE00001589
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Inclusion Criteria:

• up to 24 years old
• undergoing allogeneic or autologous HSCT
Breathing, Lung & Sleep Health
Diffuse Alveolar Hemorrhage, Hematopoietic Stem Cell Transplant (HSCT), Interstitial Pneumonitis
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MT2013-06C : Treatment of graft Failure after HSCT

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients undergoing a second transplant using a haploidentical donor, an unrelated donor or umbilical cord blood. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Troy Lund
Not specified
This study is NOT accepting healthy volunteers
1404M49341
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Inclusion Criteria:

• patients with primary or secondary HSCT graft failure
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled infection at the time of transplant
• patients with Fanconi Anemia or other DNA breakage syndromes
Clinics and Surgery Center (CSC), Failure, Hematopoietic Stem Cell Transplantation, HSCT
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00016450
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Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Cancer
Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Ashish Gupta
Not specified
This study is NOT accepting healthy volunteers
1601M82901
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Inclusion Criteria:

• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Cancer
Neuroblastoma
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MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

Punita Grover
Up to 60 years old
STUDY00001087
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Inclusion Criteria:
Age: ≤ 60 years of age Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70 Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian) Adequate Organ Function: Renal: Creatinine <2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR. Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of >95% on room air Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Other
Inclusion Criteria:
Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol. Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse. Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following: t(8,21) without cKIT mutation inv(16) or t(16;16) without cKIT mutation Normal karyotype with mutated NPM1 and wild type FLT-ITD Normal karyotype with double mutated CEBPA Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy. Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL. High risk ALL is defined as having one of the following: Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1 30 years of age or older at diagnosis White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis CNS leukemia involvement during the course of disease Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy) Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission. Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors. Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology. Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be < 10% by a representative bone marrow aspirate morphology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant. Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+. Diffuse large Cell NHL > CR/> PR: Patients in CR/PR with initial short remission (<6 months) are eligible, or those who have failed/or are not eligible for autologous transplant. Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year. Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy. Juvenile myelomonocytic leukemia Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR. MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status. Natural Killer Cell Malignancies Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
Exclusion Criteria:
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens) CML in blast crisis Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy. Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression. Active central nervous system malignancy if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant Active HIV infection or known HIV positive serology active uncontrolled infection Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
Clinics and Surgery Center (CSC)
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017906
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Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.

Veronika Bachanova, MD
Not specified
This study is NOT accepting healthy volunteers
1611M99805
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Inclusion Criteria:

• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations

The purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and Bone Marrow Transplant (BMT) databases for patients undergoing a transplant for the treatment of Dyskeratosis Congenita (DC) or Severe Aplastic Anemia (SAA). The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
1404M50183
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Inclusion Criteria:
-0 to 70 years old
• acceptable hematopoeitic stem cell donor identified
• Dyskeratosis Congenita (DC) with evidence of bone marrow failure
• Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• women who are pregnant or breast feeding
• uncontrolled infection
Blood Disorders
Clinics and Surgery Center (CSC), Aplastic Anemia, DC, Dyskeratosis Congenita, SAA
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2020IS043; MT2020-06; A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF JSP191 FOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONING TO ACHIEVE ENGRAFTMENT AND IMMUNE RECONSTITUTION IN SUBJECTS WITH SCID

This study is looking at whether giving a new type of experimental medicine, called JSP191, can prepare the body to help the stem cell transplant work better, so the immune system can grow and fight infections. The study doctor and Sponsor also want to see how safe and well tolerated this experimental medicine is. They will study whether it is safe to give to patients and look at how much medication to give and what side effects may occur. During this study, the optimal dose of JSP191 will be determined and additional patients will be enrolled in this study using that dose level.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
STUDY00010559
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Inclusion Criteria:

• at least 3 months old
• diagnosis of typical Severe Combined Immunodeficiency (SCID)
• patient with human leukocyte antigen (HLA) matched related or unrelated donors
Exclusion Criteria:

• acute or uncontrolled infections
• patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• patients with active malignancies
• active Graft-versus-host disease (GVHD) within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
Immune Diseases, Rare Diseases
SCID, Severe combined immunodeficiency
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MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors

This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.

Benjamin Manning
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019932
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Inclusion Criteria:

• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
Cancer
Clinics and Surgery Center (CSC), advanced cancer, cancer, metastatic cancer, solid tumors
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MT2023-33 A Phase II Study of Reduced Dose Post Transplantation; Cyclophosphamide as GvHD Prophylaxis in Adult Patients with Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (OPTIMIZE)

Cyclophosphamide is a chemotherapy (chemo) drug often given after a transplant to prevent graft-versus-host disease (GvHD). We are doing this study to see if a lower dose of cyclophosphamide after transplant is as safe and works just as well. This study does not include any new or untested drugs. The drugs and procedures in this study are standard for people who receive a transplant.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
SITE00002076
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Inclusion Criteria:

• between 18 and 66 years old
• receiving an unrelated Donor Peripheral Blood Stem Cell Transplantation
• willing to comply with all study procedures and availability for the duration of the study
• see link to clinicaltrials.gov for complete Inclusion Criteria
Exclusion Criteria:

• prior allogeneic transplant
• autologous transplant within the past 3 months
• women who are pregnant or breast feeding
• HIV+ with persistently positive viral load
• study staff will review
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Myelodysplastic Syndromes
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MT2022-41 A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises (BEACON Trial) (BEACON)

BEAM-101 is an experimental new therapy being developed for treating people with SCD and vaso-occlusive crises. The goal of this study is to see if BEAM-101 is safe and effective for people in the study. The study sponsor and study doctors would also like to see if individuals who are treated with BEAM-101 require fewer blood transfusions and experience fewer vasoocclusive crises requiring hospitalization, compared to before they received BEAM-101. This study will also measure the levels of fetal hemoglobin along with measures that assess quality of life and ability to function following treatment with BEAM-101.

Ashish Gupta
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017341
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Inclusion Criteria:

• 18 to 35 years old
• documented diagnosis of sickle cell disease with specific genotypes (study staff will review)
• disease is severe
Exclusion Criteria:

• HbF levels >20%, obtained at the time of screening on or off hydroxyurea therapy
• previous transplant
• history of an overt stroke
Rare Diseases, Blood Disorders
Clinics and Surgery Center (CSC), SCD, Sickle Cell Disease
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MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

The purpose of this study is to determine the safety and effectiveness of allogeneic hematopoietic cell transplant in persons with an inherited metabolic disorder or osteopetrosis and if it is effective in reducing or slowing the symptoms associated with the genetic error. The study uses a chemotherapy conditioning regimen that prepares the body to accept the donor hematopoietic cells.

Paul Orchard
Not specified
This study is NOT accepting healthy volunteers
1406M51542
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Inclusion Criteria:

• up to 55 years old
• diagnosis of an Inherited Metabolic Disorders (IMD)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled bacterial, fungal or viral infections including HIV
• women who are pregnant
Rare Diseases
Clinics and Surgery Center (CSC), Allogeneic Hematopoietic Cell Transplantation, IMD, Inherited metabolic disorders, osteopetrosis
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MT-2018-20: COG AALL1631 - International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients (> 1 year and < 21 years) with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000271
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Inclusion Criteria:

• >= 1 year (365 days) and =< 21 years at ALL diagnosis
• Diagnosis: Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or molecular methodologies. OR
• Diagnosis: ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA.
• see link to clinicaltrials.gov for complete Inclusion Criteria
Exclusion Criteria:

• known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Down syndrome
• patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
Cancer
Acute Lymphoblastic Leukemia, ALL, B Acute Lymphoblastic Leukemia, T Acute Lymphoblastic
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