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RecruitingNCT05657639Updated Dec 29, 2025

CAV Regimen for R/R AML

A Phase 2 interventional study of CAV Regimen and MEC Regimen in Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

This study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).

Read the detailed description

Patients with relapse/refractory (R/R) acute myeloid leukemia often show resistance to conventional chemotherapy and have dismal prognosis. Salvage therapy using venetoclax combined with hypomethylation drugs achieved an overall response rate of only approximately 40% in R/R AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells.The efficacy of cladribine plus cytarabine and venetoclax in R/R AML has not been reported.

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

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

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 68 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute 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
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 16-70 years old.
  2. Diagnosed with R/R AML.
  3. Patients with AML must meet one of the following criteria, A or B: A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML 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. 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 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. Patients who relapsed after allogeneic hematopoietic stem cell transplantation.
  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
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    CAV regimen

    Drug: CAV Regimen

  • Active comparator
    MEC regimen

    Drug: MEC Regimen

Interventions

  • DrugCAV Regimen

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

  • DrugMEC Regimen

    Mitoxantrone 8mg/m2 d1-5, etoposide 100mg/m2 d1-5, cytarabine 1g/m2 d1-5

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    The overall response (completed remission, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission)

    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 study 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. Event-free survival (EFS)

    EFS is measured from the time of enrollment to this study to treatment failure or relapse or any cause of death.

    Time frame: 2 years

  3. Treatment-related mortality (TRM)

    Death due to treatment (within 8 weeks) during and after completion of chemotherapy.

    Time frame: 2 months

  4. Adverse events (AEs)

    It is evaluated and graded according to CTCAE 5.0.

    Time frame: 2 months

07

Study locations

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 ↗
10

Registry details

Key details

Study ID
NCT05657639
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborators
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, Jining Medical University, The First People's Hospital of Changzhou, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Zhejiang University, YANCHENG NO.1 PEOPLE'S HOSPITAL, Kaifeng Central Hospital
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 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Dec 29, 2025

Study contacts

Sheng-Li Xue, M. D.
Contact
slxue@suda.edu.cn
008651267781139

Oversight

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

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