StudyFinder

A Multi-Site, Randomized Trial of Subject-Controlled Dried Blood Spot CMV Testing with Mobile Technology Support to Optimize Preemptive Therapy Late After Allogeneic HCT

Recruiting

Subject-Collected Dried Blood Spot CMV Testing to Optimize Preemptive Therapy Late After Allogeneic HCT

I'm interested

All
15 Years to 99 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:
Randomized Cohort:
• Must be >/= 15 years of age at the time of enrollment
• Must be able to provide written consent and complete the informed consent
• Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
• Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to randomization. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as deoxyribonucleic acid (DNA) detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Direct availability to the internet either by a computer in the residence or a smart phone
• Had at least one or more of these conditions:
• HLA mismatch*
• umbilical cord blood source**
• Graft versus host disease (GVHD)***
• T-cell depletion**** * Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
• Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for gastrointestinal (GI) GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment
• Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab Observation Cohort:
• Must be >/= 15 years of age at the time of enrollment
• Must have one of the following:
• Consented for retrospective studies at their transplant center, or
• Be included under the auspices of the site's IRB approved waiver of additional consent for retrospective studies
• Must have received allogeneic hematopoietic cell transplantation within 360 days prior to enrollment
• CMV seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to registration. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as DNA detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Meet at least one or more of criteria of the following:
• HLA mismatch*
• umbilical cord blood source**
• GVHD***
• T-cell depletion****
• Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1 **Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for GI GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment ****Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab
Exclusion Criteria:
Randomized Cohort:
• Inability to fully comprehend the study website and study procedures
• Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration Observational Cohort:
• Did not meet all inclusion criteria
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration

Device: DBS Self-Collection Kit, Other: Standard Control Strategy

Cytomegalovirus Infection

Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation, Clinics and Surgery Center (CSC)

Abdisa Taddese - tadd0009@umn.edu
Jo-Anne Young, MD
N/A
STUDY00005408
NCT03910478
See this study on ClinicalTrials.gov

Back