A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
Summary
To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.
Description
Primary Objectives * To determine the safety of recommended dose by 20 participants including 10 relapsed/refractory participants (cohort 1) and 10 newly diagnosed participants (cohort 2). * To evaluate the overall response rate (combination of complete remission \[CR\] + complete remission with incomplete count recovery \[CRi) + complete remission with incomplete hematologic recovery \[CRh\]) of the combination of SC blinatumomab and revumenib in cohort 1 and cohort 2 (participants with MRD-only disease will not be included towards the overall response rate) * To evaluate event-free survival…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria • The following groups of participants will be eligible: * Participants \> 18 years of age with relapsed and/or refractory (defined as \>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or * Participants \>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or * Newly diagnosed participants with KMT2A-r B-cell ALL \> 60 years old or unfit for intensive chemotherapy Unfit for intensive chemotherapy defined as: * ECOG \>2 * Severe cardiac disorder (e.g., congestive heart failur…
Interventions
- DrugRevumenib
Given by po
- DrugBlinatumomab
Given by IV
Location
- MD Anderson CancerHouston, Texas