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

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT03080922

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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）.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid	Biological: hematopoietic stem cell	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: hematopoietic stem cell high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

Arm

Intervention/Treatment

Experimental: 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

Biological: hematopoietic stem cell

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

Outcome Measures

Primary Outcome Measures

complete remission rate [2 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Academy of Military Medical Sciences ,	Beijing	Beijing	China	100071

Sponsors and Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

Study Chair: HUISHENG AI, Affiliated Hospital of Academy of Military Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

ClinicalTrials.gov Identifier:

NCT03080922

Other Study ID Numbers:

HD-DSI-AML

First Posted:

Mar 15, 2017

Last Update Posted:

Apr 4, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Acute Myeloid Leukemia

Relapsed

Refractory

hematopoietic stem cell

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Study Results

No Results Posted as of Apr 4, 2017