Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04874194
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2021-05-01
Brief Title:
Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase IbII Study of Omacetaxine and Venetoclax for Patients With RelapsedRefractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1
Status:
COMPLETED
Status Verified Date:
2024-10
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 IbII trial best dose possible benefits andor side effects of omacetaxine and venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back recurrent or does not respond to treatment refractory and have a genetic change RUNX1 Drugs used in chemotherapy such as omacetaxine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Venetoclax may stop the growth of cancer cells by blocking Bcl-2 a protein needed for cancer cell survival Giving omacetaxine and venetoclax may help to control the disease
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and tolerability and recommended phase 2 dose RP2D of omacetaxine in combination with venetoclax for patients with relapsedrefractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation Phase 1b II To determine the efficacy of omacetaxine in combination with venetoclax for patients with relapsedrefractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation Phase II
SECONDARY OBJECTIVES
I To determine duration of response DOR event-free survival EFS and overall survival OS
II To evaluate occurrence of minimal residual disease MRD negative status by multiparameter flow cytometry and molecular evaluation
EXPLORATORY OBJECTIVE
I To investigate global gene expression profiles deoxyribonucleic acid DNA methylation profiles BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
OUTLINE This is a phase I dose de-escalation study followed by a phase II study
Patients receive omacetaxine subcutaneously SC twice daily BID on days 2-3 or 2-4 and venetoclax orally PO on days 1-7 1-10 or 1-14 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days then every 3 months for 3 years
I To determine the safety and tolerability and recommended phase 2 dose RP2D of omacetaxine in combination with venetoclax for patients with relapsedrefractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation Phase 1b II To determine the efficacy of omacetaxine in combination with venetoclax for patients with relapsedrefractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation Phase II
SECONDARY OBJECTIVES
I To determine duration of response DOR event-free survival EFS and overall survival OS
II To evaluate occurrence of minimal residual disease MRD negative status by multiparameter flow cytometry and molecular evaluation
EXPLORATORY OBJECTIVE
I To investigate global gene expression profiles deoxyribonucleic acid DNA methylation profiles BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
OUTLINE This is a phase I dose de-escalation study followed by a phase II study
Patients receive omacetaxine subcutaneously SC twice daily BID on days 2-3 or 2-4 and venetoclax orally PO on days 1-7 1-10 or 1-14 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days then every 3 months for 3 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0890 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-03341 | REGISTRY | None | None |