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

Refractory Acute Myeloid Leukemia Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904237
• Other study ID #: RJH-rAML-2021
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong HU
• Phone: 86-21-64370045
• Email: hj10709[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Refractory Acute Myeloid Leukemia

Intervention

Drug:
• Aza-Ven-allo-HSCT
aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai
China	Department of Hematology, Shanghai No6 Hospital	Shanghai
China	Shanghai ZhaXin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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