NCT05190549

CAV Regimen Bridging to HSCT for R/R AL

CAV Regimen (Cladribine Combined With Low Dose Ara-C and Venetoclax) Pretreatment Followed by Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Acute Leukemia: a Multi-center, Open-label and Prospective Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CAV (cladribine combined with low dose Ara-C and venetoclax) regimens followed by HSCT treatment protocol for R/R AML.

Conditions

• Acute Leukemia, Relapsed
• Acute Leukemia Refractory

Interventions

Type	Name	Description
PROCEDURE	CAV regimen bridging to HSCT	The enrolled patients will be firstly given CAV bridging regimen (cladribine 5mg/m2/ day for 5 days, cytarabine 20mg q12h for 10 days, and began at 100 mg on day 1 and increased stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, and 400 mg) on days 1-21. Conditioning regimen for allo-HSCT may be administrated after completion of the CAV regimen, with or without consolidation therapy.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-11-17
• Completion: 2024-11-17
• First posted: 2022-01-13
• Last updated: 2024-11-20

Locations

1 site across 1 country: China