NCT06474663

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

To find the recommended dose of the drug combination cladribine, cytarabine, decitabine, and sorafenib in participants with relapsed/refractory AML, MPAL, and ALAL.

Detailed description

Primary Objectives - To determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of cladribine, low-dose cytarabine, sorafeneib alternating with decitabine for pediatric participants with acute leukemias. Secondary Objectives \- To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (CRi), Morphologic leukemia free state (MLFS) and partial remission (PR), overall survival (OS), event-free survival (EFS) and duration of response (DOR) of pediatric participants treated with this combination.

Conditions

• Refractory Acute Leukemia
• Relapsed Acute Leukemia

Interventions

Type	Name	Description
DRUG	Cladribine	Given by IV
DRUG	Cytarabine	Given by SC
DRUG	Sorafenib	Given by PO
DRUG	Decitabine	Given by IV

Timeline

• Start date: 2025-07-31
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-06-26
• Last updated: 2025-08-06

Regulatory

• FDA-regulated drug study