Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Brief Title:
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
Status:
NOT_YET_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:
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia
Detailed Description:
Primary Objectives
To determine the maximum tolerated dose MTD and the recommended Phase 2 dose RP2D of venetoclax in combination with hyper-CVAD in patients with relapsed or refractory acute leukemias that are of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias
To characterize the safety and tolerability of hyper-CVAD in combination with venetoclax
Secondary Objectives
To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with incomplete blood count recovery CRi and partial response PR
Evaluate additional measures of clinical benefit including overall survival OS event-free survival EFS progression-free survival PFS minimal residual disease MRD rate and duration of response DOR
Exploratory Objectives
To evaluate the pharmacodynamics PD and biological effects of hyper-CVAD in combination with venetoclax through molecular and cellular markers that may be predictive of antitumor activity andor resistance
To determine the maximum tolerated dose MTD and the recommended Phase 2 dose RP2D of venetoclax in combination with hyper-CVAD in patients with relapsed or refractory acute leukemias that are of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias
To characterize the safety and tolerability of hyper-CVAD in combination with venetoclax
Secondary Objectives
To determine the preliminary assessment of efficacy by overall response OR including complete remission CR CR with incomplete blood count recovery CRi and partial response PR
Evaluate additional measures of clinical benefit including overall survival OS event-free survival EFS progression-free survival PFS minimal residual disease MRD rate and duration of response DOR
Exploratory Objectives
To evaluate the pharmacodynamics PD and biological effects of hyper-CVAD in combination with venetoclax through molecular and cellular markers that may be predictive of antitumor activity andor resistance
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-2024-05154 | OTHER | None | None |