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OpenTrials
Completed

NCT Number: NCT02028650

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

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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Key information

Conditions

Relapse Leukemia

Age range

9 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the first donor's stem cell

Biological

HLA-matched stem cell infusion

the second donor's stem cell

Biological

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

Primary outcomes

  1. Number of Participants with graft versus host diseases

    Time frame: 100 days

Secondary outcomes

  1. Time to Disease Progression

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

huishengai

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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