New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
Primary Purpose
Leukemia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prophylactic GPBPCI
Sponsored by

About this trial
This is an interventional prevention trial for Leukemia
Eligibility Criteria
Inclusion Criteria:
- high-risk leukemia after HSCT
Exclusion Criteria:
- active GVHD
- early relapse
Sites / Locations
- Lanzhou General Hospital of Lanzhou Command
- Nanfang Hospital, Southern Medical University
- The First Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Medical School of Zhejiang University
- Peking University People's Hospital,Institute of Hematology
- Xinqiao Hospital,Third Military Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
high-risk leukemia
Arm Description
Outcomes
Primary Outcome Measures
relapse rate
Secondary Outcome Measures
survival probability
Full Information
NCT ID
NCT01455272
First Posted
October 12, 2011
Last Updated
April 5, 2015
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01455272
Brief Title
New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
Official Title
Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.
It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.
The study hypothesis:
Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can
reduce relapse rate
improve survival
Detailed Description
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-risk leukemia
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
prophylactic GPBPCI
Other Intervention Name(s)
modified DLI
Intervention Description
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
Primary Outcome Measure Information:
Title
relapse rate
Time Frame
one year after HSCT
Secondary Outcome Measure Information:
Title
survival probability
Time Frame
one year after transplant
10. Eligibility
Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high-risk leukemia after HSCT
Exclusion Criteria:
active GVHD
early relapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoJun Huang, M.D.
Organizational Affiliation
Peking University People's Hospital,Institute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lanzhou General Hospital of Lanzhou Command
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University People's Hospital,Institute of Hematology
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Xinqiao Hospital,Third Military Medical University
City
Chongqing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32103499
Citation
Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
Results Reference
derived
PubMed Identifier
28483716
Citation
Yan CH, Liu QF, Wu DP, Zhang X, Xu LP, Zhang XH, Wang Y, Huang H, Bai H, Huang F, Ma X, Huang XJ. Prophylactic Donor Lymphocyte Infusion (DLI) Followed by Minimal Residual Disease and Graft-versus-Host Disease-Guided Multiple DLIs Could Improve Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Refractory/Relapsed Acute Leukemia. Biol Blood Marrow Transplant. 2017 Aug;23(8):1311-1319. doi: 10.1016/j.bbmt.2017.04.028. Epub 2017 May 5. Erratum In: Biol Blood Marrow Transplant. 2020 Jan;26(1):214.
Results Reference
derived
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New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
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