Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT06466395
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
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:
M.D. Anderson Cancer Center
Organization:
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:
RECRUITING
Status Verified Date:
2025-09
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 and/or 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 and/or resistance.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-05154 | OTHER | NCI-CTRP Clinical Registry | View |