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

NCT ID: NCT04904237

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Refractory Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aza-ven +MBF

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

Group Type EXPERIMENTAL

Aza-Ven-allo-HSCT

Intervention Type DRUG

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

Interventions

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Aza-Ven-allo-HSCT

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

Intervention Type DRUG

Other Intervention Names

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Aza-Ven MBF

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head BMT program, Rui Jin Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiong HU

Role: PRINCIPAL_INVESTIGATOR

Shanghai Rui Jin Hospital

Locations

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Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, , China

Site Status RECRUITING

Department of Hematology, Shanghai No6 Hospital

Shanghai, , China

Site Status RECRUITING

Shanghai ZhaXin Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiong HU

Role: CONTACT

86-21-64370045 ext. 601878

Jie-ling Jiang

Role: CONTACT

86-21-64370045 ext. 601878

Facility Contacts

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Jiong HU, M.D.

Role: primary

86-21-64370045 ext. 601818

Chunkang Chang

Role: primary

86-21-64369181

Chun Wang

Role: primary

13386259777

Other Identifiers

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RJH-rAML-2021

Identifier Type: -

Identifier Source: org_study_id

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