Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Part of paid clinical trials in The Bronx, New York.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06308588
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — DRUG
    Given by Infusion
  • Asciminib — DRUG
    Given by PO

Study Details

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Key Dates

Start date
Aug 5, 2024
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
May 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blinatumomab + Asciminib
    Participants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant. Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5. Participants will take asciminib by mouth 2 times every day during this study.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10467
Marina Konopleva, MD
[email protected]
718-920-4826
Marina Konopleva, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Nicholas Short, MD
[email protected]
713-563-4485
Nicholas Short, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in The Bronx, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Montefiore Einstein Comprehensive Cancer Center· The Bronx, NYMD Anderson Cancer Center· Houston, TX

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