Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia

Not Applicable

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia; Phase 2 Study; Blinatumomab
• Interventions: Drug: Blinatumomab

• Registration Number: NCT07192237
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.

Detailed Description

Primary Objectives To evaluate the efficacy of SQ blinatumomab in participants with MRD positive B-cell ALL in morphological remission through Relapse free survival

Secondary Objectives

1. Rate of NGS MRD negativity (at a sensitivity of 10-6) after 2 cycles of therapy and cumulative rates of NGS MRD negativity (and PCR for BCR::ABL1 for Ph+ B-cell ALL)

2. Duration of sustained NGS MRD negativity at 10-6

3. 12- month sustained NGS MRD negativity at 10-6 for participants in first remission and 6-month sustained NGS MRD negativity for participants beyond first remission

4. Event free survival and modified event free survival (mEFS)

5. Overall survival

6. Toxicity

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Study First Posted: 2025-09-25
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-03
• Study Start: 2026-02-27
• Primary Completion: 2030-10-12
• Study Completion: 2032-10-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SQ blinatumomab	Blinatumomab	Receiving blinatumomab as injections under the skin. The drug will be given in 35-day (5-week) treatment cycles. The injections may be given on various parts of the body, including the upper arm, thigh, stomach, and/or hips/buttocks.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States