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CompletedNCT02028650Updated Jul 13, 2016

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

An observational study in Relapse Leukemia, sponsored by huishengai. Completed at 1 site in China. Open to participants aged 9 Years to 67 Years. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by huishengai · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
9 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Relapse Leukemia

Keywords

  • relapse leukemia
  • DSI
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

This is the only study on the registry with huishengai as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients without receiving CR will not receive further post-remission trial therapy
  • The patients of AML-M3 were excluded from this study.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • the first donor

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

    Biological: the first donor's stem cell

  • the second donor

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

    Biological: the second donor's stem cell

Interventions

  • Biologicalthe first donor's stem cell

    HLA-matched stem cell infusion

  • Biologicalthe second donor's stem cell

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

06

What researchers measure

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

07

Study locations

1 site
  • Affiliated Hospital of Academy of Military Medical Sciences
    Beijing, Beijing 100071, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02028650
Lead sponsor
huishengai
Responsible party
huishengai (director of Hematology Department, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences) — Sponsor-investigator
First posted
Jan 7, 2014
Start date
Feb 2005
Primary completion
Feb 2013
Completion
Oct 2014
Last update
Jul 13, 2016

Study contacts

qiao jianhui, MD
principal investigator · Affiliated Hospital of Academy of Military Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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