CAV Regimen for R/R Ph- B-ALL

NCT05657652 | Recruiting

• 1 other identifier: SZBALL01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Lymphoblastic Leukemia

Keywords

venetoclax; cladribine; cytarabine; relapsed/refractory ALL

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

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

Secondary Outcomes (3)

• Overall Survival (OS)

  2 years

• Progression-Free Survival (PFS)

  2 years

• Adverse events

  1 month

Study Arms (1)

CAV regimen

EXPERIMENTAL

Drug: cladribine, cytarabine,venetoclax

Interventions

cladribine, cytarabine,venetoclax 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: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

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 of 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Jining Medical University: collaborator
• 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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Interventions

Cladribine; Cytarabine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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

Locations

CN (1)