- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02028650
Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
July 12, 2016 updated by: huishengai
HLA-mismatched Peripheral Hematopoietic Stem Cells Infusion in the Treatment of Leukemia Patients Relapse After HLA- Matched Allogeneic Stem Cell Transplantation: A Randomized Clinical Trial
The relapse leukemia patients after transplantation were divided into two groups randomly.
Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without chemotherapy; group D2: patients received second-donor DSI treatment with or without chemotherapy.
The second donors were preferably donors who were genetically related and had more HLA-match locus.
The re-induction chemotherapy regimen was primarily MAT(mitoxantrone, cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide, cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation indications include bone marrow morphology,hematopoietic recovery (neutrophil and platelet), 100-day transplantation-related mortality (TRM), donor chimerism, acute GVHD, chronic GVHD, disease free survival (DFS), and overall survival (OS).
The cut-time of the follow-up was Oct, 2013.
DFS was defined as the time between the date of transplantation to the death or relapse.
OS was defined as the time from diagnosis to death or to the last date of follow-up until Oct. 2013.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Affiliated Hospital of Academy of Military Medical Sciences
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-
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
9 years to 67 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Eligible patients were between 9 and 67 years of age with de novo diagnosed or treated-related Acute leukemia relapsed after HLA-matched hematological stem cell transplantation from Feb 2005 to Feb 2013.
Description
Inclusion Criteria:
- Eligible patients were between 9 and 67 years of age with de novo diagnosed or treated-related Acute leukemia relapsed after HLA-matched hematological stem cell transplantation from Feb 2005 to Feb 2013
- Relapse was morphologically and molecularly diagnosed,with the help of cytogenetic and engraftment.
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 to 2
Exclusion Criteria:
- Patients without receiving CR will not receive further post-remission trial therapy
- The patients of AML-M3 were excluded from this study.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
the first donor
the original donor applicable patients were assigned to receive the first donor's stem cell treatment after G-CSF mobilization or combination chemotherapy
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HLA-matched stem cell infusion
|
the second donor
HLA-mismatched, the second donor's stem cell infusion
|
HLA-mismatched, the second donor's stem cell infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with graft versus host diseases
Time Frame: 100 days
|
100 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Disease Progression
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: qiao jianhui, MD, 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
February 1, 2005
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 1, 2014
First Submitted That Met QC Criteria
January 4, 2014
First Posted (Estimate)
January 7, 2014
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 12, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL13-307PLAH-AHS
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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