CAV Regimen for R/R AML

NCT05657639 | Recruiting Phase 2

• 1 other identifier: SZAML02
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Myeloid Leukemia

Keywords

venetoclax; cladribine; cytarabine; relapsed/refractory AML

Outcome Measures

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)

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

Secondary Outcomes (4)

• Overall Survival (OS)

  2 years

• Event-free survival (EFS)

  2 years

• Treatment-related mortality (TRM)

  2 months

• Adverse events (AEs)

  2 months

Study Arms (2)

CAV regimen

EXPERIMENTAL

Drug: CAV Regimen

MEC regimen

ACTIVE COMPARATOR

Drug: MEC Regimen

Interventions

MEC Regimen DRUG

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

MEC regimen

CAV Regimen DRUG

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

CAV regimen

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 16-70 years old.
• Diagnosed with R/R AML.
• 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.
• \. 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.

You may not qualify 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.
• 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).
• 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.
• Patients who relapsed after allogeneic hematopoietic stem cell transplantation.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The Second People's Hospital of Huai'an: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator
• Jining Medical University: collaborator
• The First People's Hospital of Changzhou: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• YANCHENG NO.1 PEOPLE'S HOSPITAL: collaborator
• Kaifeng Central Hospital: collaborator

Study Sites (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CAV regimen; MEC regimen

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Sheng-Li Xue, M. D.

CONTACT

008651267781139; slxue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)