Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575296
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor effective in treating patients with acute leukemia after allogeneic stem cell transplant
Detailed 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 GVHD-free relapse-free survival GRFS at 1 and 2 years from first dose of revumenib
II Non-relapse mortality NRM at 100 days 1 and 2 years after first dose of revumenib
III Evaluate the rate and grading of acute GVHD at 180 days after alloHCT IV Evaluate the incidence and grading of chronic GVHD cGVHD at 1 and 2 years after first dose of revumenib
V Evaluate minimal residual disease MRD using quantitative polymerase chain reaction PCR NPM1m or ClonoSeq B-acute lymphoblastic leukemia B-ALL
VI Evaluate MRD using flow cytometry VII Evaluate the feasibility of maintenance therapy
EXPLORATORY OBJECTIVES
I Evaluate immune cell populations and immune reconstitution after maintenance therapy
II Evaluate the inflammatory cytokine profile and levels III Evaluate detection of residual NPM1m error-corrected sequencing IV Develop and evaluate a novel KMT2Ar assay in detecting residual disease V Evaluate quality of life
OUTLINE This is a dose-escalation study of revumenib followed by a dose-expansion study
Starting 50-150 days after alloHCT patients receive revumenib orally PO once daily QD or every 12 hours on days 1-28 of each cycle Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Additionally patients undergo bone marrow biopsy during screening and may undergo echocardiography ECHO during screening and as clinically indicated Patients also undergo bone marrow aspiration and collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 2 years post-treatment start
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 GVHD-free relapse-free survival GRFS at 1 and 2 years from first dose of revumenib
II Non-relapse mortality NRM at 100 days 1 and 2 years after first dose of revumenib
III Evaluate the rate and grading of acute GVHD at 180 days after alloHCT IV Evaluate the incidence and grading of chronic GVHD cGVHD at 1 and 2 years after first dose of revumenib
V Evaluate minimal residual disease MRD using quantitative polymerase chain reaction PCR NPM1m or ClonoSeq B-acute lymphoblastic leukemia B-ALL
VI Evaluate MRD using flow cytometry VII Evaluate the feasibility of maintenance therapy
EXPLORATORY OBJECTIVES
I Evaluate immune cell populations and immune reconstitution after maintenance therapy
II Evaluate the inflammatory cytokine profile and levels III Evaluate detection of residual NPM1m error-corrected sequencing IV Develop and evaluate a novel KMT2Ar assay in detecting residual disease V Evaluate quality of life
OUTLINE This is a dose-escalation study of revumenib followed by a dose-expansion study
Starting 50-150 days after alloHCT patients receive revumenib orally PO once daily QD or every 12 hours on days 1-28 of each cycle Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Additionally patients undergo bone marrow biopsy during screening and may undergo echocardiography ECHO during screening and as clinically indicated Patients also undergo bone marrow aspiration and collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 2 years post-treatment start
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None