CAV Regimen Bridging to HSCT for R/R AL

NCT05190549 | Completed Phase 2

• 1 other identifier: SZRRAL01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Leukemia, Relapsed; Acute Leukemia Refractory

Keywords

CAV regimen; HSCT

Outcome Measures

Primary Outcomes (1)

• ORR (overall response rate)

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

  1 month

Secondary Outcomes (3)

• OS (Overall survival)

  1 year

• EFS (Event-free survival)

  1 year

• Adverse events (AEs)

  2 months

Study Arms (1)

CAV Regimen Bridging to HSCT

EXPERIMENTAL

Procedure: CAV regimen bridging to HSCT

Interventions

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.

CAV Regimen Bridging to HSCT

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The Second People's Hospital of Huai'an: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheng-Li Xue, M.D.

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 13, 2022
• Study Start: October 1, 2021
• Primary Completion: November 17, 2024
• Study Completion: November 17, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)