High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

Phase 1

• Conditions: Leukemia, Myeloid
• Interventions: Biological: hematopoietic stem cell

• Registration Number: NCT03080922
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

Detailed Description

The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.

no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2017-03
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-15
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patient with relapsed and/or refractory AML
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

• Previous treatment with investigational gene or cell therapy medicine products
• Any uncontrolled active medical disorder that would preclude participation as outlined

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hematopoietic stem cell	hematopoietic stem cell	high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

Primary Outcome Measures

Name	Time	Method
complete remission rate	2 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	2 years
Overall survival	2 years
donor graft rate	6 months
Occurrence of study related adverse events	6 months	defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Trial Locations

Locations (1)

Affiliated Hospital of Academy of Military Medical Sciences ,; 🇨🇳 Beijing, Beijing, China