CVA Regimen Bridging to HSCT for R/R AL

  • End date
    Oct 1, 2023
  • participants needed
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 3 May 2022


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 CVA (cladribine combined with venetoclax and low dose Ara-C) regimens followed by HSCT treatment protocol for R/R AML.

Condition Acute Leukemia, Relapsed, Acute Leukemia Refractory
Treatment CVA regimen bridging to HSCT
Clinical Study IdentifierNCT05190549
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on3 May 2022


Yes No Not Sure

Inclusion Criteria

Patients with AL must meet one of the following criteria :A or B. A: relapsed AL disease was defined as follows: (1) Reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of >5% blasts in the bone marrow (BM) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse
refractory AL disease was defined as follows: (1): failure to attained CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI)<50% and >15% blast existence after one course of standard or intensive induction therapy
patients without serious disease of heart or liver or lung or kidneys
sign informed consent voluntarily
Patients aged between 18 and 65 years old, male or female is permitted
ECOG performance status score less than 1
The expected survival is longer than 3 months

Exclusion Criteria

With other malignant tumors
Patients received the treatment of cladribine or venetoclax
Patients received cardiac angioplasty or stent implantation
Active infections that are not under clinical control (bacteria or fungus or virus is included)
Liver functions abnormalities (total bilirubin>1.5 times the upper limit of the normal range, ALT/AST>2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST>1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine>1.5 times the upper limit of normal value)
Pregnant or nursing women
Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
Patients participated in any other clinical trials 3 months prior to signing the informed consent
Patients not suitable for the study according to the investigator's assessment
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