Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-31 @ 5:00 AM
Study NCT ID:
NCT03728335
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Phase 2 Trial of Enasidenib (AG-221) Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients With IDH2 Mutation
Status:
RECRUITING
Status Verified Date:
2025-02
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 II trial studies the side effects of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
1\. Evaluate the efficacy of enasidenib as post-HCT maintenance therapy in patients with mIDH2 AML, at 2-years post-HCT.
SECONDARY OBJECTIVES:
1. Assess overall (OS) and leukemia-free survival (LFS) at 1 and 2 years post-HCT;
2. Estimate the cumulative incidence of chronic GVHD at 1 and 2 years post-HCT;
3. Estimate the cumulative incidence of relapse, non-relapse mortality (NRM), GVHD and relapse free survival (GRFS) at 1 and 2 years post-HCT.
EXPLORATORY OBJECTIVES:
1. Monitor disease status among subset of patients with MRD positive disease when start to receive Enasidenib by multiparameter flow cytometry post allogeneic HCT on patients BM on days +100 and +365;
2. Investigate clearance of IDH2 mutation post HCT by NGS-PCR testing on the bone marrow specimens on days +100 and +365 and in peripheral blood every 3 months till 2 year follow up; and
OUTLINE:
Patients receive enasidenib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and periodically thereafter up to 2 years.
1\. Evaluate the efficacy of enasidenib as post-HCT maintenance therapy in patients with mIDH2 AML, at 2-years post-HCT.
SECONDARY OBJECTIVES:
1. Assess overall (OS) and leukemia-free survival (LFS) at 1 and 2 years post-HCT;
2. Estimate the cumulative incidence of chronic GVHD at 1 and 2 years post-HCT;
3. Estimate the cumulative incidence of relapse, non-relapse mortality (NRM), GVHD and relapse free survival (GRFS) at 1 and 2 years post-HCT.
EXPLORATORY OBJECTIVES:
1. Monitor disease status among subset of patients with MRD positive disease when start to receive Enasidenib by multiparameter flow cytometry post allogeneic HCT on patients BM on days +100 and +365;
2. Investigate clearance of IDH2 mutation post HCT by NGS-PCR testing on the bone marrow specimens on days +100 and +365 and in peripheral blood every 3 months till 2 year follow up; and
OUTLINE:
Patients receive enasidenib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and periodically thereafter up to 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: