Back to results

Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.

Primary Purpose

Refractory Acute Myeloid Leukemia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Aza-Ven-allo-HSCT

About this trial

This is an interventional treatment trial for Refractory Acute Myeloid Leukemia focused on measuring refractory, acute myeloid leukemia, hematopoietic stem cell transplantation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
patients with HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor

Exclusion Criteria:

Patients with poor liver function (enzyme >2N or bilirubin >2N)
poor renal function (Scr >1.5N)
poor cardiac function （EF<45%）
inform consent not provided

Sites / Locations

Blood & Marrow Transplantation Center, RuiJin HospitalRecruiting
Department of Hematology, Shanghai No6 HospitalRecruiting
Shanghai ZhaXin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aza-ven +MBF

Arm Description

treatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning

Outcomes

Primary Outcome Measures

relapse-free survival

event defined as relapse or death of any causes

Secondary Outcome Measures

overall survival

event defined as death of all causes

non-relapse mortality

event defined as death of all causes other than leukemia relapse

relapse

event defined as leukemia relapse

GVHD and relapse free survival (GRFS)

event defined as leukemia relapse, death of any causes, III-IV aGVHD or moderate to severe cGVHD

Full Information

NCT ID

NCT04904237

First Posted

May 22, 2021

Last Updated

May 27, 2021

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04904237

Brief Title

Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.

Official Title

Azacytidine-venetoclax Combination as Leukemia Debulking Treatment Followed by Reduced Toxicity Conditioning Regimen (Melphalan Busulfan and Fludarabine, MBF) as Salvage Therapy for Refractory Acute Myeloid Leukemia (AML).

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

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

In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .

Detailed Description

In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feasibility of new sequential transplantation protocol. All patients receive azacytidine and venetoclax as leukemia debulking treatment which is followed by reduced intensity conditioning regimen consisting of Fludarabine (150mg/m2) + Busulfan (6.4mg/kg) + Melphalan (70mg/m2). The graft-versus host disease (GVHD) prophylaxis regimen is based on reduced dose of post-transplantation cyclophosphamide (PT-CY) 40mg/kg day+3~+4, tacrolimus and low-dose anti-thymoglobulin (ATG, 2.5mg/kg) in case of HLA-matched unrelated donor or halo-donor transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Acute Myeloid Leukemia

Keywords

refractory, acute myeloid leukemia, hematopoietic stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aza-ven +MBF

Arm Type

Experimental

Arm Description

treatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning

Intervention Type

Drug

Intervention Name(s)

Aza-Ven-allo-HSCT

Other Intervention Name(s)

Aza-Ven MBF

Intervention Description

aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan

Primary Outcome Measure Information:

Title

relapse-free survival

Description

event defined as relapse or death of any causes

Time Frame

12 months

Secondary Outcome Measure Information:

Title

overall survival

Description

event defined as death of all causes

Time Frame

12 months

Title

non-relapse mortality

Description

event defined as death of all causes other than leukemia relapse

Time Frame

12 months

Title

relapse

Description

event defined as leukemia relapse

Time Frame

12 months

Title

GVHD and relapse free survival (GRFS)

Description

event defined as leukemia relapse, death of any causes, III-IV aGVHD or moderate to severe cGVHD

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML patients with HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor Exclusion Criteria: Patients with poor liver function (enzyme >2N or bilirubin >2N) poor renal function (Scr >1.5N) poor cardiac function （EF<45%） inform consent not provided

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiong HU

Phone

86-21-64370045

Ext

601878

hj10709@rjh.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jie-ling Jiang

Phone

86-21-64370045

Ext

601878

jiangjieling66@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiong HU

Organizational Affiliation

Shanghai Rui Jin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Blood & Marrow Transplantation Center, RuiJin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiong HU, M.D.

Phone

86-21-64370045

Ext

601818

hj10709@rjh.com.cn

Facility Name

Department of Hematology, Shanghai No6 Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chunkang Chang

Phone

86-21-64369181

changchunkang@sjtu.edu.cn

Facility Name

Shanghai ZhaXin Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chun Wang

Phone

13386259777

wangchun2@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.

We'll reach out to this number within 24 hrs