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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

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:

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 18 and 65 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.

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

NCT ID

NCT05190549

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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.

slxue@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

CAV Regimen Bridging to HSCT for R/R AL

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