Clinical trial NCT02028650: Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapse Leukemia
Keywords: relapse leukemia
DSI
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with graft versus host diseases
timeFrame: 100 days
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: qiao jianhui, MD
role: PRINCIPAL_INVESTIGATOR
References: