Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Relapse Leukemia

Intervention / Treatment
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* Biological: the first donor's stem cell
* Biological: the second donor's stem cell


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the first donor<br>the original donor applicable patients were assigned to receive the first donor's stem cell treatment after G-CSF mobilization or combination chemotherapy | Biological: the first donor's stem cell<br>* HLA-matched stem cell infusion<br>|
| the second donor<br>HLA-mismatched, the second donor's stem cell infusion | Biological: the second donor's stem cell<br>* HLA-mismatched, the second donor's stem cell infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with graft versus host diseases |  | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DSI, relapse leukemia