StudyFinder
COG AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to < 31 Years Old with First Relapse
Status: Recruiting
The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.
Sex: Male or Female
Age Group: 1 year to 30 years old
Inclusion Criteria:
• 1 to 30 years old
• must have first relapse of CD19+ B-ALL (relapse blasts must express CD19)
• must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• see link to clinicaltrials.gov for completed Inclusion criteria
Exclusion Criteria:
• other types of blood disorders including: B-lymphoblastic lymphoma (B-LLy), Burkitt leukemia/lymphoma or mature B-cell leukemia, Philadelphia chromosome positive (Ph+) B-ALL, mixed phenotype acute leukemia (MPAL), known Charcot-Marie-Tooth disease, MYC translocation associated with mature (Burkitt) B-cell ALL
• active, uncontrolled infection
• significant central nervous system pathology including history of severe neurologic disorder or autoimmune disease with CNS involvement
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:
Cancer
Keywords:
Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia
Study Contact: Allison Fullenkamp - fulle631@umn.edu
Principal Investigator: Peter Gordon
Phase: PHASE2
IRB Number: SITE00001178
See this study on ClinicalTrials.gov