Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2021-10-01
2024-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAV Regimen Bridging to HSCT
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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%.
2. patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
3. sign informed consent voluntarily.
4. Patients aged between 16 and 70 years old, male or female is permitted.
5. ECOG performance status score less than 1.
6. The expected survival is longer than 3 months.
Exclusion Criteria
2. Patients received the treatment of cladribine or venetoclax.
3. Patients received cardiac angioplasty or stent implantation.
4. Active infections that are not under clinical control (bacteria or fungus or virus is included).
5. 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).
6. Pregnant or nursing women.
7. 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.
8. Patients participated in any other clinical trials 3 months prior to signing the informed consent.
9. Patients not suitable for the study according to the investigator's assessment.
16 Years
70 Years
ALL
No
Sponsors
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The Second People's Hospital of Huai'an
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Sheng-Li Xue, MD
Prof.
Principal Investigators
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Sheng-Li Xue, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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SZRRAL01
Identifier Type: -
Identifier Source: org_study_id
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