Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797767
Status:
SUSPENDED
Last Update Posted:
2024-05-21
First Post:
2021-03-10
Brief Title:
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase 1 Single-Center Trial Combining Venetoclax With G-CSF Cladribine Cytarabine and Mitoxantrone CLAG-M for Patients With AML and High-Grade Myeloid Neoplasms
Status:
SUSPENDED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Phase transitionstudy design changes - additional phasecohortarms pending Start-up activity temporarily suspended
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 finds the best dose and side effects of venetoclax in combination with cladribine cytarabine granulocyte colony-stimulating factor and mitoxantrone CLAG-M in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms Venetoclax may stop the growth of cancer cells by blocking Bcl-2 a protein needed for cancer cell survival Chemotherapy drugs such as cladribine cytarabine and mitoxantrone work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving venetoclax with CLAG-M may kill more cancer cells
Detailed Description:
OUTLINE
This is a dose-escalation study of venetoclax
Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 if peripheral white blood cell count is less than 20000uL cladribine on days 1-5 cytarabine on 1-5 and mitoxantrone on days 1-3 Patients also receive venetoclax orally PO on days 1-14 Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 12 months
This is a dose-escalation study of venetoclax
Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 if peripheral white blood cell count is less than 20000uL cladribine on days 1-5 cytarabine on 1-5 and mitoxantrone on days 1-3 Patients also receive venetoclax orally PO on days 1-14 Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 12 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 |
|---|---|---|---|
| NCI-2021-01379 | REGISTRY | None | None |
| 10793 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |