Blinatumomab Bridging Therapy for BALL

NCT04556084 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: Blina Part 1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-cell Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia; Relapsed B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects in Complete Remission (CR)

  The primary efficacy variable is the percent of subjects that remain in Complete Remission (CR) after completion of 1 or 2 cycles of blinatumomab. Complete remission was defined as \<5% blasts in the bone marrow. Complete remission was further defined as minimal residual disease (MRD) positive (\>/= to 0.01%) or MRD negative (\<0.01%) as measured by flow cytometry of the bone marrow.

  1 or 2 Months depending on the number of cycles of blinatumomab

• Percentage of Subjects Flow Cytometry (FC) -Minimal Residual Disease (MRD) Negative Defined as <0.01% Leukemia

  The primary efficacy variable is the percent of subjects that become Flow Cytometry-MRD negative (FC-MRD negative) \< 0.01% after completion of 1 or 2 cycles of blinatumomab.

  1 to 2 Months depending on the number of cycles of blinatumomab

Secondary Outcomes (1)

• Percentage of Subjects That Are High-Throughput Deep Sequencing (HTS)-Minimal Residual Disease (MRD) Negative Defined as Undetectable

  After completion of Blinatumomab bridging therapy (1 participant's course consisted of 1 cycle, the other participant's course consisted of 2 cycles)

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Up to 2 cycles of continuous infusion blinatumomab will be given based on the end of Cycle 1 disease response. Cycle 2 of blinatumomab can be given to subjects who have achieved remission (\< 5% marrow blasts) after Cycle 1 but have persistent disease identified by multi-parameter flow cytometry (minimal residual disease (MRD) positive ≥ 0.01%) after Cycle 1.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Blinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling. Patient weight greater than or equal to 45kg will receive 28 mcg/day Patient weight less than 45kg will receive 15 mcg/m2/day

Also known as: Blincyto

Blinatumomab

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Patients with very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL);
• 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 Score ≥ 50 for patients under 16 years of age (see Appendix 1)
• Have acceptable organ function as defined within 7 days of study registration:
• 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.

You may not qualify if:

• 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.
• Known allergy to blinatumomab
• Participating in a concomitant Phase 1 or 2 study

Sponsors & Collaborators

• Michael Burke: lead
• Amgen: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Michael Burke
• Organization: Medical College of Wisconsin

mmburke@mcw.edu

4149554198

Study Officials

• Michael Burke, MD

  Medical College of Wisconsin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics, Division of Hematology/Oncology/BMT

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 21, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Locations

US (1)