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Completed

NCT Number: NCT05190549

CAV Regimen Bridging to HSCT for R/R AL

Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CAV (cladribine combined with low dose Ara-C and venetoclax) regimens followed by HSCT treatment protocol for R/R AML.

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Key information

Conditions

Acute Leukemia, Relapsed Acute Leukemia Refractory Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with AL must meet one of the following criteria ：A or B. A: relapsed AL disease was defined as follows: (1) Reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of >5% blasts in the bone marrow (BM) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse.

B: refractory AL disease was defined as follows: (1) failure to achieve CR, CRh or CRi after two courses of intensive induction treatment. or (2) failure to achieve complete remission after one cycle of induction chemotherapy or a reduction in the number of blasts of less than 50% after one cycle of induction treatment, with residual blasts >15%.

  • patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
  • sign informed consent voluntarily.
  • Patients aged between 16 and 70 years old, male or female is permitted.
  • ECOG performance status score less than 1.
  • The expected survival is longer than 3 months.

Exclusion criteria

  • With other malignant tumors.
  • Patients received the treatment of cladribine or venetoclax.
  • Patients received cardiac angioplasty or stent implantation.
  • Active infections that are not under clinical control (bacteria or fungus or virus is included).
  • Liver functions abnormalities (total bilirubin>1.5 times the upper limit of the normal range, ALT/AST>2.5 times 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 anomalies (serum creatinine>1.5 times the upper limit of normal value).
  • Pregnant or nursing women.
  • Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
  • Patients participated in any other clinical trials 3 months prior to signing the informed consent.
  • Patients not suitable for the study according to the investigator's assessment.

Treatment and study plan

CAV regimen bridging to HSCT

Procedure

The enrolled patients will be firstly given CAV bridging regimen (cladribine 5mg/m2/ day for 5 days, cytarabine 20mg q12h for 10 days, and began at 100 mg on day 1 and increased stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, and 400 mg) on days 1-21. Conditioning regimen for allo-HSCT may be administrated after completion of the CAV regimen, with or without consolidation therapy.

Primary outcomes

  1. ORR (overall response rate)

    Time frame: 1 month

    ORR was calculated as the sum of CR, CRi, MLFS and PR.

Secondary outcomes

  1. OS (Overall survival)

    Time frame: 1 year

    OS was defined as the time from 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.

  2. EFS (Event-free survival)

    Time frame: 1 year

    EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.

  3. Adverse events (AEs)

    Time frame: 2 months

    It is evaluated and graded according to CTCAE 5.0.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • The Second People's Hospital of Huai'an

Registry information

Official study title

CAV Regimen (Cladribine Combined With Low Dose Ara-C and Venetoclax) Pretreatment Followed by Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Acute Leukemia: a Multi-center, Open-label and Prospective Clinical Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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