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New treatment option for Acute Lymphoblastic Leukemia
Official title CAV Regimen for R/R Ph- B-ALL
ClinicalTrials.gov ID: NCT05657652
What this study is testing
What is cladribine, cytarabine,venetoclax?
cladribine, cytarabine,venetoclax is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 70
You may be able to join if
- Aged 15-70 years old.
- Patients diagnosed with R/R Ph- B-ALL.
- 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...
- ECOG performance status score less than 2.
- Expected survival time ≥ 12 weeks.
You likely can't join if
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
- Patients with mental disorders or other conditions.
See the full eligibility criteria
- Aged 15-70 years old.
- Patients diagnosed with R/R Ph- B-ALL.
- 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...
- ECOG performance status score less than 2.
- Expected survival time ≥ 12 weeks.
- Patients without serious heart, lung, liver, or kidney dysfunction.
- Able to understand and provide informed consent.
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
- Patients with mental disorders or other conditions.
- 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...
- 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...
- Surgery on the main organs within the past six weeks.
- Drug abuse or long-term alcohol abuse that would affect the evaluation results.
- Patients who have received organ transplants.
- Patients not suitable for the study according to the investigator's assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.