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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RECRUITING
NA
36 participants
INTERVENTIONAL
2022-10-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAV regimen
cladribine, cytarabine,venetoclax
Cladribine 5 mg/m2/day, cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.
Interventions
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cladribine, cytarabine,venetoclax
Cladribine 5 mg/m2/day, cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with R/R Ph- B-ALL.
3. Patients with ALL must meet one of the following criteria, A or B: A: Refractory ALL disease was defined as follows: (1) failure to attain CR following exposure to at least 1 courses of standard induction therapy; B: Relapsed ALL disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
4. ECOG performance status score less than 2.
5. Expected survival time ≥ 12 weeks.
6. Patients without serious heart, lung, liver, or kidney dysfunction.
7. Able to understand and provide informed consent.
Exclusion Criteria
2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
6. Patients with mental disorders or other conditions.
7. Liver function abnormalities (total bilirubin \> 1.5 times of the upper limit of the normal range, ALT/AST \> 2.5 times of the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times of the upper limit of the normal range), or renal dysfunction (Ccr\<50ml/h).
8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants.
12. Patients not suitable for the study according to the investigator's assessment.
15 Years
70 Years
ALL
No
Sponsors
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Jining Medical University
OTHER
The Second People's Hospital of Huai'an
OTHER
The First Affiliated Hospital of Bengbu Medical University
OTHER
Northern Jiangsu People's Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Suzhou Hospital of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Sheng-Li Xue, MD
Professor
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Facility Contacts
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Sheng-Li Xue, M.D.
Role: primary
Other Identifiers
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SZBALL01
Identifier Type: -
Identifier Source: org_study_id