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

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 2

Conditions: Refractory Acute Myeloid Leukemia

Treatments: Drug: Aza-Ven-allo-HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT04904237

RJH-rAML-2021

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

aza-ven +MBF

Experimental group

Description:

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

Treatment:

Drug: Aza-Ven-allo-HSCT