Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543381
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML MDS or CMML After Donor Hematopoietic Cell Transplant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial of Olutasidenib Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients Carrying IDH1 Mutation With AML MDS or CMML Disease
Status:
RECRUITING
Status Verified Date:
2024-08
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 and effectiveness of olutasidenib in preventing the return of disease relapse in patients who have undergone donor allogeneic hematopoietic cell transplant for acute myeloid leukemia AML myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML carrying an IDH1 mutation Olutasidenib is in a class of medications called IDH1 inhibitors It works by slowing or stopping the growth of cancer cells Giving olutasidenib may be safe tolerable andor effective in preventing relapse in patients with IDH1 mutated AML MDS or CMML after an allogeneic hematopoietic cell transplant
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the safety and tolerability of olutasidenib as maintenance therapy after allogeneic hematopoietic cell transplantation HCT in patients with IDH1-mutated acute myeloid leukemia AML myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML
SECONDARY OBJECTIVES
I Assess overall survival OS and leukemia-free survival LFS at 1 and 2 years after first dose of olutasidenib
II Estimate cumulative incidence of relapse CIR non-relapse mortality NRM graft-versus-host disease GVHD free relapse-free survival GRFS at 1 and 2 years after first dose of olutasidenib
III Rate and grading of acute GVHD of grades 2-4 and 3-4 at day 100 post allogeneic HCT
IV Incidence and grading of chronic GVHD of all grades at 1 and 2 years after first dose of olutasidenib
EXPLORATORY OBJECTIVES
I Monitor disease status by multiparameter flow cytometry among a subset of patients with minimal residual disease MRD disease when starting olutasidenib
II Molecular monitoring of disease status by HopeSeq complete at City of Hope COH and equivalent next generation sequencing NGS assay at Cleveland Clinic
III Monitor immune reconstitution by flow cytometry during protocol therapy IV Mutant mIDH1 testing on peripheral blood samples with standard polymerase chain reaction PCR
V Investigate IFN-ɣ signaling in immune cell subsets before and during maintenance therapy
VI Monitor mIDH1 variant allele fraction VAF by droplet digital PCR ddPCR beads emulsion amplification magnetics BEAMing technology on peripheral blood
OUTLINE
Starting 50-120 days after bone marrow transplant patients receive olutasidenib orally PO twice daily BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection on study
After completion of study treatment patients are followed up at 30 days and then up to 2 years
I Evaluate the safety and tolerability of olutasidenib as maintenance therapy after allogeneic hematopoietic cell transplantation HCT in patients with IDH1-mutated acute myeloid leukemia AML myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML
SECONDARY OBJECTIVES
I Assess overall survival OS and leukemia-free survival LFS at 1 and 2 years after first dose of olutasidenib
II Estimate cumulative incidence of relapse CIR non-relapse mortality NRM graft-versus-host disease GVHD free relapse-free survival GRFS at 1 and 2 years after first dose of olutasidenib
III Rate and grading of acute GVHD of grades 2-4 and 3-4 at day 100 post allogeneic HCT
IV Incidence and grading of chronic GVHD of all grades at 1 and 2 years after first dose of olutasidenib
EXPLORATORY OBJECTIVES
I Monitor disease status by multiparameter flow cytometry among a subset of patients with minimal residual disease MRD disease when starting olutasidenib
II Molecular monitoring of disease status by HopeSeq complete at City of Hope COH and equivalent next generation sequencing NGS assay at Cleveland Clinic
III Monitor immune reconstitution by flow cytometry during protocol therapy IV Mutant mIDH1 testing on peripheral blood samples with standard polymerase chain reaction PCR
V Investigate IFN-ɣ signaling in immune cell subsets before and during maintenance therapy
VI Monitor mIDH1 variant allele fraction VAF by droplet digital PCR ddPCR beads emulsion amplification magnetics BEAMing technology on peripheral blood
OUTLINE
Starting 50-120 days after bone marrow transplant patients receive olutasidenib orally PO twice daily BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection on study
After completion of study treatment patients are followed up at 30 days and then up to 2 years
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