- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080922
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
March 30, 2017 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HUISHENG AI
- Email: HUISHNGAI@163.COM
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Recruiting
- Affiliated Hospital of Academy of Military Medical Sciences ,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
complete remission rate
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
|
Disease-free survival
Time Frame: 2 years
|
2 years
|
|
donor graft rate
Time Frame: 6 months
|
6 months
|
|
Occurrence of study related adverse events
Time Frame: 6 months
|
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: HUISHENG AI, Affiliated Hospital of Academy of Military Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
March 10, 2017
First Submitted That Met QC Criteria
March 10, 2017
First Posted (Actual)
March 15, 2017
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
March 30, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD-DSI-AML
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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