A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged ≥1 to <31 Years Old With First Relapse
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321.841.5357 ; 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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IRB No: AALL1821
Protocol Abbrev: AALL1821
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase II
Age Group: Adult;Pediatric
Secondary Protocol No: AALL1821
Treatment: Radiation: 3-Dimensional Conformal Radiation Therapy; Biological: Blinatumomab; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Drug: Etoposide; Drug: Hydrocortisone Sodium Succinate; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Biological: Nivolumab; Drug: Pegaspargase; Drug: Thioguanine; Drug: Vincristine Sulfate
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04546399
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Objective
1 - Minimal residual disease (MRD) negative second remission (Rem-2) rate (Group 1) [ Time Frame: Up to 2 cycles of therapy (each cycle = 36 days) ]
Will be defined as Rem-2 and bone marrow with MRD < 0.01% by flow cytometry. Will be compared using a one-sided Z test of proportions with type I error of 0.10.
2 - Event-free survival post-induction (Group 3) [ Time Frame: From date of randomization to date of relapse, disease progression, second malignancy (SMN) or death due to any cause, assessed up to 3 years ]
The primary analysis between Arm E versus Arm F will be based on a one-sided two-sample logrank test with type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. -
Key Eligibility
Ages Eligible for Study: 1 Year to 30 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
