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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2014-10-31

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.

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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.

Conditions

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Relapse Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

the first donor's stem cell

Intervention Type BIOLOGICAL

HLA-matched stem cell infusion

the second donor

HLA-mismatched, the second donor's stem cell infusion

the second donor's stem cell

Intervention Type BIOLOGICAL

HLA-mismatched, the second donor's stem cell infusion

Interventions

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the first donor's stem cell

HLA-matched stem cell infusion

Intervention Type BIOLOGICAL

the second donor's stem cell

HLA-mismatched, the second donor's stem cell infusion

Intervention Type BIOLOGICAL

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