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

NCT02028650 | Completed DMC

• 1 other identifier: RL13-307PLAH-AHS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapse Leukemia

Keywords

relapse leukemia; DSI

Outcome Measures

Primary Outcomes (1)

• Number of Participants with graft versus host diseases

  100 days

Secondary Outcomes (1)

• Time to Disease Progression

  2 years

Study Arms (2)

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

the first donor's stem cell BIOLOGICAL

HLA-matched stem cell infusion

the first donor

the second donor's stem cell BIOLOGICAL

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

the second donor

Eligibility Criteria

• Age: 9 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• huishengai: lead

Study Sites (1)

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

the blood and bone marrow samples before and after transplantation and DSI

Study Officials

• qiao jianhui, MD

  Affiliated Hospital of Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of Hematology Department

Study Record Dates

• First Submitted: January 1, 2014
• First Posted: January 7, 2014
• Study Start: February 1, 2005
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2014
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

CN (1)