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

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).

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04904237

Enrollment

Registered

2021-05-27

Start date

2021-01-01

Completion date

2024-06-01

Last updated

2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Acute Myeloid Leukemia

Keywords

refractory, acute myeloid leukemia, hematopoietic stem cell transplantation

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.

Interventions

DRUGAza-Ven-allo-HSCT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
relapse-free survival	12 months	event defined as relapse or death of any causes

Secondary

Measure	Time frame	Description
overall survival	12 months	event defined as death of all causes
non-relapse mortality	12 months	event defined as death of all causes other than leukemia relapse
relapse	12 months	event defined as leukemia relapse
GVHD and relapse free survival (GRFS)	12 months	event defined as leukemia relapse, death of any causes, III-IV aGVHD or moderate to severe cGVHD

Countries

China

Contacts

Primary ContactJiong HU

hj10709@rjh.com.cn86-21-64370045

Backup ContactJie-ling Jiang

jiangjieling66@hotmail.com86-21-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026