MedTrace Logo

CAV Regimen Bridging to HSCT for R/R AL

NCT05190549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Sheng-Li Xue, M.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-11-17
Completion
2024-11-17

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190549 on ClinicalTrials.gov