Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311227
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-13
Brief Title:
Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Venetoclax in Relapsed Classic or Variant Hairy Cell Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
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 II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement relapsed 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
Detailed Description:
PRIMARY OBJECTIVE
I To determine the objective response rate ORR of venetoclax
SECONDARY OBJECTIVES
I To determine the complete remission CR and minimal residual disease MRD-negative CR rates of venetoclax in relapsed hairy cell leukemiahairy cell leukemia variant HCLHCLv
II To determine the rates of MRD-negative by blood flow cytometry with venetoclax
III To determine the safety of venetoclax in relapsed HCLHCLv IV To determine the response and CR duration and MRD-negative survival in relapsed HCLHCLv receiving venetoclax
EXPLORATORY OBJECTIVES
I To correlate response to TP53 mutations and other mutations particularly for BRAF wild-type WT relapsed HCLHCLv
II To perform whole exome sequencing WES of relapsed HCLHCLv samples to look for mutations to correlate with response
OUTLINE
Patients receive venetoclax orally PO once daily QD on days 1-28 of each cycle Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the study Patients may undergo bone marrow biopsy andor aspiration on study
After completion of study treatment patients are followed up at 30 days
I To determine the objective response rate ORR of venetoclax
SECONDARY OBJECTIVES
I To determine the complete remission CR and minimal residual disease MRD-negative CR rates of venetoclax in relapsed hairy cell leukemiahairy cell leukemia variant HCLHCLv
II To determine the rates of MRD-negative by blood flow cytometry with venetoclax
III To determine the safety of venetoclax in relapsed HCLHCLv IV To determine the response and CR duration and MRD-negative survival in relapsed HCLHCLv receiving venetoclax
EXPLORATORY OBJECTIVES
I To correlate response to TP53 mutations and other mutations particularly for BRAF wild-type WT relapsed HCLHCLv
II To perform whole exome sequencing WES of relapsed HCLHCLv samples to look for mutations to correlate with response
OUTLINE
Patients receive venetoclax orally PO once daily QD on days 1-28 of each cycle Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the study Patients may undergo bone marrow biopsy andor aspiration on study
After completion of study treatment patients are followed up at 30 days
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 |
|---|---|---|---|
| 10637 | OTHER | CTEP | None |
| NCI-2024-01904 | REGISTRY | None | None |
| 10637 | OTHER | None | None |