NCT06466395

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Acute Leukemia
• Relapsed Acute Leukemia
• Undifferentiated Leukemia
• Bi-Phenotypic Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Given by PO
DRUG	Hyper-CVAD	Given by IV

Timeline

• Start date: 2025-02-18
• Primary completion: 2027-12-31
• Completion: 2031-12-31
• First posted: 2024-06-20
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study