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

huishengai

Status: Completed

Conditions: Relapse Leukemia

Treatments: Biological: the second donor's stem cell; Biological: the first donor's stem cell

Study type: Observational

Funder types: Other

Identifiers

NCT02028650

RL13-307PLAH-AHS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 9 to 67 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

the first donor

Description:

the original donor applicable patients were assigned to receive the first donor's stem cell treatment after G-CSF mobilization or combination chemotherapy

Treatment:

Biological: the first donor's stem cell

the second donor

Description:

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

Treatment:

Biological: the second donor's stem cell