Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Mea… (NCT07192237) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia
United States40 participantsStarted 2026-09-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like).
* ECOG Performance status of 0, 1, or 2.
* Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg/dl and ALT and/or AST less than or equal to 5 times institutional upper limit of normal.
* The effects of blinatumomab on the developing human fetus are unknown. For this reason and because bispecific T-cell engager agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:
* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
* History of hysterectomy or bilateral salpingo-oophorectomy.
* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
* History of bilateral tubal ligation or ano…
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year