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RecruitingNCT05657652Updated Dec 29, 2025

CAV Regimen for R/R Ph- B-ALL

An interventional study of cladribine, cytarabine,venetoclax in Acute Lymphoblastic Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
15 Years to 70 Years
Sex
All
01

Study summary

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).

Read the detailed description

Relapse is common in Ph- B-ALL and a proportion of patients present refractory to initial treatment. Treatments for these patients consist immunotherapy and conventional chemotherapy. The former is too expensive and the latter has a low remission rate. Treatment for R/R Ph- B-ALL still remains a challenge. The efficacy and safety of cladribine, venetoclax and cytarabine (CAV) has not been explored in ALL. Thus investigators design such a clinical trial to investigate the efficacy and safety of CAV regimen for R/R Ph- B-ALL.

02

Conditions studied

  • Acute Lymphoblastic Leukemia

Keywords

  • venetoclax
  • cladribine
  • cytarabine
  • relapsed/refractory ALL
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 36 is close to the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 15-70 years old.
  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

Exclusion Criteria:

  1. Patients who are allergic to the study drug or drugs with similar chemical structures.
  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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    CAV regimen

    Drug: cladribine, cytarabine,venetoclax

Interventions

  • Drugcladribine, cytarabine,venetoclax

    Cladribine 5 mg/m2/day, cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    The overall response (completed remission, completed remission with incomplete blood count recovery)

    Time frame: ORR assessment is measured on days 21 from the start of CAV regimen

Secondary outcomes

  1. Overall Survival (OS)

    OS is measured from the time of enrollment to this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

    Time frame: 2 years

  2. Progression-Free Survival (PFS)

    PFS is measured from the time of enrollment to this study to progression or death.

    Time frame: 2 years

  3. Adverse events

    It is evaluated and graded according to CTCAE 5.0.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05657652
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine
Responsible party
Sheng-Li Xue, MD (Professor, The First Affiliated Hospital of Soochow University) — Principal investigator
First posted
Dec 20, 2022
Start date
Oct 1, 2022
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Dec 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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