A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Revumenib
  • Blinatumomab

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Amgen

Collaborator

Syndax Pharmaceuticals

Collaborator