Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399640
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-30
Brief Title:
Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome MDS or acute myeloid leukemia AML that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory Eltanexor works by trapping tumor suppressing proteins within the cell thus causing the cancer cells to die or stop growing Venetoclax is in a class of medications called B-cell lymphoma-2 BCL-2 inhibitors It may stop the growth of cancer cells by blocking Bcl-2 a protein needed for cancer cell survival Giving eltanexor together with venetoclax may be safe tolerable andor effective in treating patients with relapsed or refractory MDS or AML
Detailed Description:
Primary objective
To establish the safe and biologically effective dose BED of eltanexor in combination with venetoclax in patients with RR MDS andor AML
Secondary objectives
To estimate the complete remission CR rate with eltanexor and venetoclax in patients with RR MDS andor AML
To assess the overall response rate ORR following treatment with eltanexorvenetoclax
To assess the overall survival of patients
To assess the progression free survival PFS and duration of response DOR in patients treated with eltanexorvenetoclax
Exploratory objectives
To assess differential response between MDS and AML cohorts
To develop and evaluate a phenotypic flow-based assay to predict response to eltanexorvenetoclax
To assess the effect of mutational changes on response to eltanexorvenetoclax
To measure the rates of measurable residual disease with eltanexorvenetoclax
OUTLINE This is a dose-escalation study of eltanexor in combination with venetoclax
Patients receive eltanexor orally PO once per day QD for 5 days per week for 14 21 or 28 days every cycle and venetoclax PO QD on days 1-14 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for up to 24 months
To establish the safe and biologically effective dose BED of eltanexor in combination with venetoclax in patients with RR MDS andor AML
Secondary objectives
To estimate the complete remission CR rate with eltanexor and venetoclax in patients with RR MDS andor AML
To assess the overall response rate ORR following treatment with eltanexorvenetoclax
To assess the overall survival of patients
To assess the progression free survival PFS and duration of response DOR in patients treated with eltanexorvenetoclax
Exploratory objectives
To assess differential response between MDS and AML cohorts
To develop and evaluate a phenotypic flow-based assay to predict response to eltanexorvenetoclax
To assess the effect of mutational changes on response to eltanexorvenetoclax
To measure the rates of measurable residual disease with eltanexorvenetoclax
OUTLINE This is a dose-escalation study of eltanexor in combination with venetoclax
Patients receive eltanexor orally PO once per day QD for 5 days per week for 14 21 or 28 days every cycle and venetoclax PO QD on days 1-14 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for up to 24 months
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 |
|---|---|---|---|
| 1R01CA262287-01 | NIH | NCI Clinical Trials Reporting Program | httpsreporternihgovquickSearch1R01CA262287-01 |
| NCI-2024-03343 | REGISTRY | None | None |