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NCT03080922 Clinical Trial

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

Leukemia, Myeloid Clinical Trial

Official title:
Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03080922
Other study ID # HD-DSI-AML
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received March 10, 2017
Last updated March 30, 2017
Start date March 2016
Est. completion date March 2019

Study information
Verified date March 2017
Source The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Contact HUISHENG AI
Email HUISHNGAI@163.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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）.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date March 2019
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• hematopoietic stem cell
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

Locations
Country Name City State
China Affiliated Hospital of Academy of Military Medical Sciences , Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary complete remission rate 2 months
Secondary Disease-free survival 2 years
Secondary Overall survival 2 years
Secondary donor graft rate 6 months
Secondary Occurrence of study related adverse events defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment 6 months
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