A Phase I Study of SNDX 5613 (Revumenib) as Post-Transplant Maintenance After Allogeneic Hematopoietic Cell Transplant in Patients With KMT2A-Rearranged or NPM1-Mutated Acute Leukemia
City of Hope Medical Center
Summary
This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of revumenib as maintenance therapy in patients with KMT2A rearranged or NPM1 mutated acute leukemia after undergoing allogeneic hematopoietic cell transplantation (alloHCT). II. Determine the recommended phase 2 dose (RP2D) of revumenib as maintenance therapy in patients with KMT2A rearranged (KMT2Ar) or NPM1 mutated (NPM1m) acute leukemia after undergoing alloHCT. SECONDARY OBJECTIVES: I. Assess overall survival (OS), relapse free survival (RFS), cumulative incidence of relapse (CIR), and composite graft versus host disease (GVH…
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PATIENTS WHO ARE SCHEDULED TO UNDERGO HEMATOPOIETIC CELL TRANSPLANTATION (HCT) OR THOSE WHO HAVE UNDERGONE HCT: Documented informed consent of the participant and/or legally authorized representative * PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Agreement to allow the use of archival tissue from diagnostic tumor biopsies; if unavailable, exceptions may be granted with study principal investigator (PI) approval * PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participant is willing and able to adhere to the study…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureEchocardiography
Undergo ECHO
- OtherElectronic Health Record Review
Ancillary studies
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Location
- City of Hope Medical CenterDuarte, California