Blinatumomab Bridging Therapy

  • STATUS
    Recruiting
  • End date
    Oct 20, 2024
  • participants needed
    35
  • sponsor
    Michael Burke
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Updated on 20 April 2022
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Summary

The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes.

Description

The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. This Phase 2 study will determine the effectiveness of delivering 1 to 2 cycles of blinatumomab (Days 1-28) as bridging therapy in children, adolescent and young adults with relapse or persistent MRD B-ALL. Eligible subjects will receive 1 or 2, 28-day cycles of blinatumomab prior to proceeding to HCT. Centralized MRD assessment will be performed after completion of the 28-days of blinatumomab using both flow cytometry (University of Washington, Brent Wood, MD) and High-Throughput Deep Sequencing (HTS) MRD technologies (Adaptive Technologies, Seattle, WA). Subjects who achieve flow cytometry negative MRD (<0.01%) after a single cycle of blinatumomab can proceed directly to HCT whereas subjects who remain MRD positive by flow cytometry may receive a 2nd cycle of blinatumomab. Subjects who remain MRD positive by flow cytometry after a 2nd cycle of blinatumomab will come off study.

Details
Condition B-cell Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04556084
SponsorMichael Burke
Last Modified on20 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of B-ALL in hematologic complete remission (defined as an M1 marrow, < 5% blasts) with MRD in the bone marrow (≥ 0.01%) by multi-parameter flow cytometry and that meets one of the following
Patients in first relapse or greater
OR
• Patients with very-high risk biology ALL that is proceeding to HCT in first remission
(e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL)
OR
• Patients who have persistent MRD after Consolidation therapy (End of Consolidation (EOC)
MRD positive ≥ 0.01%)
AND with the intent of going on to an allogeneic hematopoietic cell transplantation (HCT)
independent of this study
Patients must have an available donor and have intention of proceeding directly to HCT
after completion of 1 to 2 cycles of Bridging therapy with blinatumomab
Age ≤ 25 years at time of study enrollment
Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play
Have acceptable organ function as defined within 7 days of study registration
Score ≥ 50 for patients under 16 years of age (see Appendix 1)
Renal: creatinine clearance ≥ 60 mL/min/1.73m2 or serum creatinine based on age/gender
Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of
normal (ULN) for age
Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA
At least 7 days must have elapsed from prior chemotherapy
Patients who have experienced their relapse after HCT are eligible, provided they have
no evidence of acute or chronic Graft-versus-Host Disease (GVHD) and are off all
transplant immune suppression therapy for at least 7-days (e.g. steroids
cyclosporine, tacrolimus). Steroid therapy for non-GVHD and/or non-leukemia therapy is
acceptable
Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic
agent. For agents that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which adverse
events are known to occur. The duration of this interval must be discussed with the
study chair
Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after
the last dose of monoclonal antibody (i.e. Inotuzumab = 12 days)
Immunotherapy: At least 42 days after the completion of any type of immunotherapy
(e.g. tumor vaccines or CAR T-cell therapy)
XRT: Cranio or craniospinal XRT is prohibited during protocol therapy. ≥ 90 days must
have elapsed if prior TBI, cranio or craniospinal XRT
Sexually active females of child-bearing potential must agree to use adequate
contraception (diaphragm, birth control pills, injections, intrauterine device [IUD]
surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration
of treatment and for 2 months after the last dose of chemotherapy. Sexually active men
must agree to use barrier contraceptive for the duration of treatment and for 2 months
after the last dose of chemotherapy
Voluntary written consent before performance of any study-related procedure not part
of normal medical care, with the understanding that consent may be withdrawn by the
subject at any time without prejudice to future medical care

Exclusion Criteria

Known allergy to blinatumomab
Participating in a concomitant Phase 1 or 2 study
History of CNS3 disease and/or active central nervous system (CNS) disease (≥ CNS2)
Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other
anti-cancer therapy other than is specified in the protocol
Systemic fungal, bacterial, viral, or other infection not controlled (defined as
exhibiting ongoing signs/symptoms related to the infection and without improvement
despite appropriate antibiotics or other treatment)
Pregnant or lactating. The agents used in this study are known to be teratogenic to a
fetus and there is no information on the excretion of agents into breast milk. All
females of childbearing potential must have a blood test or urine study within 7-days
prior to the start of blinatumomab to rule out pregnancy
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