Back to resultsHigh Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
Primary Purpose
Leukemia, Myeloid
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
hematopoietic stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid focused on measuring Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell
Eligibility Criteria
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
Sites / Locations
- Affiliated Hospital of Academy of Military Medical Sciences ,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hematopoietic stem cell
Arm Description
high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
Outcomes
Primary Outcome Measures
complete remission rate
Secondary Outcome Measures
Disease-free survival
Overall survival
donor graft rate
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
Full Information
NCT ID
NCT03080922
First Posted
March 10, 2017
Last Updated
March 30, 2017
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03080922
Brief Title
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
Official Title
Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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）.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid
Keywords
Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hematopoietic stem cell
Arm Type
Experimental
Arm Description
high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
Intervention Type
Biological
Intervention Name(s)
hematopoietic stem cell
Intervention Description
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
Primary Outcome Measure Information:
Title
complete remission rate
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
Title
donor graft rate
Time Frame
6 months
Title
Occurrence of study related adverse events
Description
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HUISHENG AI
Email
HUISHNGAI@163.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HUISHENG AI
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences ,
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huisheng Ai, MD
Phone
86-1066947126
Email
huishengai@163.com
First Name & Middle Initial & Last Name & Degree
Huisheng Ai, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
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