MD Anderson's phase 2 trial of subcutaneous blinatumomab in MRD-positive B-ALL listed as suspended

A phase 2 study testing subcutaneous blinatumomab in patients with measurable residual disease (MRD) positive B-cell acute lymphoblastic leukemia has been marked suspended, according to a clinicaltrials.gov record last updated on 2026-10-08. The listing gives the reason for the stoppage as a request from the principal investigator.¹

The trial, registered under NCT07192237 with sponsor study ID 2025-0933, is led by M.D. Anderson Cancer Center, with Amgen listed as a collaborator.¹ It is designed 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.¹

The study's primary objective is to evaluate the efficacy of SQ blinatumomab in participants with MRD positive B-cell ALL in morphological remission through Relapse free survival.¹ Secondary objectives include rates of NGS MRD negativity after two cycles of therapy, duration of sustained MRD negativity, 12-month sustained MRD negativity for first-remission participants and 6-month for others, event-free and modified event-free survival, overall survival, and toxicity.¹

The drug is administered in 35-day treatment cycles, with injections given on the upper arm, thigh, stomach, or hips and buttocks.¹ The design is a single-group, phase 2 trial with enrollment estimated at 40 participants.¹

Eligible participants must be at least 18 years old with documented B-cell ALL showing recurrent or persistent MRD at a sensitivity of 10-6 while in morphological remission, including Ph-negative, Ph-positive and Ph-like disease.¹

The trial began on 2026-04-21 (actual)¹ and was first posted on 2025-09-25 (actual).¹ Estimated primary completion is listed as 2030-10-12¹ with study completion estimated at 2032-10-12.¹ The only listed site is MD Anderson Cancer Center in Houston, Texas, United States.¹