A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
2 other identifiers
interventional
60
1 country
1
Brief Summary
This is a single arm open-label phase 2 trial to study the safety and efficacy of SC Blinatumomab in combination with low-intensity chemotherapy for older or unfit patients with B-ALL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2026
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2033
May 5, 2026
February 1, 2026
5.7 years
September 3, 2025
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (2)
Age 18-59 years or 60-70 years: Mini-CVD + MTX/ARA-C + Blinatumomab
EXPERIMENTALParticipants who are 60-70 years of age or 18-59 years of age and unfit for intensive chemotherapy will receive a total of 8 cycles of induction-consolidation cycles.
Age>70 years: Mini-CVD + Blinatumomab
EXPERIMENTALParticipants older than 70 years of age will receive 1 cycle of mini-CVD in combination with SC Blinatumomab followed by SC Blinatumomab alone for 7 cycles for a total of 8 cycles of treatment.
Interventions
Given by IV
Given by IV
Eligibility Criteria
You may qualify if:
- Patients 60 years or older with previously untreated Ph-negative B-ALL. Patients may have received minimal prior therapy before (up to 2 cycles of previous therapy)
- Patients 18 to 59 years of age with previously untreated Ph-negative B-ALL who are deemed medically unfit for intensive chemotherapy. Patients may have received minimal prior therapy (up to 2 cycles of previous therapy)
- Unfit patients are defined as having at least one of the below comorbidities:
- COG \>2
- Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \<50%, or chronic stable angina)
- Severe pulmonary disorder (e.g., DLCO \<65% or FEV1 \<65%)
- Hepatic disorder with total bilirubin 1.5 x upper limit of normal
- ECOG Performance status of 0, 1, or 2.
- Adequate organ function with estimated creatinine clearance of \> 50 mg/min/1.73m2, bilirubin less than or equal to 3.5 mg, ALT and/or AST less than or equal to 5 times institutional upper limit of normal.
- 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 another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab administration.
- +1 more criteria
You may not qualify if:
- Pregnant women are excluded from this study because blinatumomab is a Class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomab, breastfeeding should be discontinued if the mother is treated with blinatumomab These potential risks may also apply to other agents used in this study.
- Women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Female subjects of childbearing potential unwilling/unable to use highly effective method of contraception during treatment and for an additional 4 months after the last dose of SC blinatumomab
- Prior history of therapy with SC Blinatumomab
- Philadelphia positive (+) B-ALL
- Known HIV-positive patients
- Patients with active inflammatory or infectious hepatitis. Patients with evidence of chronic hepatitis B infection must have undetectable HBV viral load on suppressive therapy. For patients with a history of Hepatitis C, infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Active and uncontrolled disease/infection as judged by the treating physician
- Patients with a cardiac ejection fraction as measured by MUGA or TTE \<40%
- Unable/unwilling to sign informed consent form
- No other investigational therapy within the past 14 days
- Symptomatic CNS disease at the time of enrollment.
- History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (\> or = grade 3) CNS events including ICANS from prior CART or other T cell engager therapies.
- No other concurrent anti-leukemia therapy will be allowed, except for BCR::ABL1 tyrosine kinase inhibitors in patients with Ph-like ALL where tyrosine kinase inhibitors have been shown to be effective.
- Current uncontrolled autoimmune disease or history of autoimmune disease with potential CNS involvement.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Amgencollaborator
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elias Jabbour, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 4, 2025
Study Start
January 30, 2026
Primary Completion (Estimated)
September 30, 2031
Study Completion (Estimated)
September 30, 2033
Last Updated
May 5, 2026
Record last verified: 2026-02