NCT02028650

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: huishengai · Academic / Other
• Sex: All
• Age: 9 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapse Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	the first donor's stem cell	HLA-matched stem cell infusion
BIOLOGICAL	the second donor's stem cell	HLA-mismatched, the second donor's stem cell infusion

Timeline

• Start date: 2005-02-01
• Primary completion: 2013-02-01
• Completion: 2014-10-01
• First posted: 2014-01-07
• Last updated: 2016-07-13

Locations

1 site across 1 country: China