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

Relapse Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028650
• Other study ID #: RL13-307PLAH-AHS
• Status: Completed
• Phase: N/A
• First received: January 1, 2014
• Last updated: July 12, 2016
• Start date: February 2005
• Est. completion date: October 2014

Study information

• Verified date: July 2016
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 67 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Recurrence
• Relapse Leukemia

Intervention

Biological:
• the first donor's stem cell
HLA-matched stem cell infusion
• the second donor's stem cell
HLA-mismatched, the second donor's stem cell infusion

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
huishengai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with graft versus host diseases		100 days	Yes
Secondary	Time to Disease Progression		2 years	Yes