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.
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
ECOG >2
Active serious infection not controlled by oral or IV antibiotics
Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
Participants with psychiatric illness that would limit compliance with study requirements
Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)
Single group
Revumenib
DrugGiven by po
Blinatumomab
DrugGiven by IV
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
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This trial is not recruiting at the moment. You can still explore other options:
