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

Completed

• Conditions: Relapse Leukemia
• Interventions: Biological: the second donor's stem cell; Biological: the first donor's stem cell

• Registration Number: NCT02028650
• Lead Sponsor: huishengai

Brief Summary

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

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 Timeline

• Study Start: 2005-02
• Primary Completion: 2013-02
• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-04
• Study First Posted: 2014-01-07
• Study Completion: 2014-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the second donor	the second donor's stem cell	HLA-mismatched, the second donor's stem cell infusion
the first donor	the first donor's stem cell	the original donor applicable patients were assigned to receive the first donor's stem cell treatment after G-CSF mobilization or combination chemotherapy

Primary Outcome Measures

Name	Time	Method
Number of Participants with graft versus host diseases	100 days

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression	2 years

Trial Locations

Locations (1)

Affiliated Hospital of Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China