Status:
COMPLETED
CAV Regimen Bridging to HSCT for R/R AL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
The Second People's Hospital of Huai'an
Conditions:
Acute Leukemia, Relapsed
Acute Leukemia Refractory
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
- B: refractory AL disease was defined as follows: (1) failure to achieve CR, CRh or CRi after two courses of intensive induction treatment. or (2) failure to achieve complete remission after one cycle of induction chemotherapy or a reduction in the number of blasts of less than 50% after one cycle of induction treatment, with residual blasts \>15%.
- patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
- sign informed consent voluntarily.
- Patients aged between 16 and 70 years old, male or female is permitted.
- ECOG performance status score less than 1.
- The expected survival is longer than 3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05190549
Start Date
October 1 2021
End Date
November 17 2024
Last Update
November 20 2024
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006