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CAV Regimen Bridging to HSCT for R/R AL

Primary Purpose

Acute Leukemia, Relapsed, Acute Leukemia Refractory

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CAV regimen bridging to HSCT
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia, Relapsed focused on measuring CAV regimen, HSCT

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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 attained 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 >15% blast existence after one course of standard or intensive induction therapy.

  2. patients without serious disease of heart or liver or lung or kidneys.
  3. sign informed consent voluntarily.
  4. Patients aged between 18 and 65 years old, male or female is permitted.
  5. ECOG performance status score less than 1.
  6. The expected survival is longer than 3 months.

Exclusion Criteria:

  1. With other malignant tumors.
  2. Patients received the treatment of cladribine or venetoclax.
  3. Patients received cardiac angioplasty or stent implantation.
  4. Active infections that are not under clinical control (bacteria or fungus or virus is included).
  5. 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).
  6. Pregnant or nursing women.
  7. 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.
  8. Patients participated in any other clinical trials 3 months prior to signing the informed consent.
  9. Patients not suitable for the study according to the investigator's assessment.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAV Regimen Bridging to HSCT

Arm Description

Outcomes

Primary Outcome Measures

ORR (overall response rate)
ORR was calculated as the sum of CR, CRi, MLFS and PR.

Secondary Outcome Measures

OS (Overall survival)
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.
EFS (Event-free survival)
EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.
Adverse events (AEs)
It is evaluated and graded according to CTCAE 5.0.

Full Information

First Posted
January 4, 2022
Last Updated
August 16, 2023
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The Second People's Hospital of Huai'an
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1. Study Identification

Unique Protocol Identification Number
NCT05190549
Brief Title
CAV Regimen Bridging to HSCT for R/R AL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The Second People's Hospital of Huai'an

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Relapsed, Acute Leukemia Refractory
Keywords
CAV regimen, HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAV Regimen Bridging to HSCT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
CAV regimen bridging to HSCT
Intervention Description
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 Outcome Measure Information:
Title
ORR (overall response rate)
Description
ORR was calculated as the sum of CR, CRi, MLFS and PR.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
OS (Overall survival)
Description
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.
Time Frame
1 year
Title
EFS (Event-free survival)
Description
EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.
Time Frame
1 year
Title
Adverse events (AEs)
Description
It is evaluated and graded according to CTCAE 5.0.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 attained 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 >15% blast existence after one course of standard or intensive induction therapy. patients without serious disease of heart or liver or lung or kidneys. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Li Xue, M.D.
Phone
008651267781139
Email
slxue@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Li Xue, M.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Li Xue, M.D.
Email
slxue@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

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CAV Regimen Bridging to HSCT for R/R AL

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