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New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01455272
First received: October 12, 2011
Last updated: March 24, 2014
Last verified: March 2014

October 12, 2011
March 24, 2014
July 2009
January 2014   (final data collection date for primary outcome measure)
relapse rate [ Time Frame: one year after HSCT ] [ Designated as safety issue: No ]
  • relapse rate [ Time Frame: two years after HSCT ] [ Designated as safety issue: Yes ]
  • survival probability [ Time Frame: two years after transplantation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01455272 on ClinicalTrials.gov Archive Site
survival probability [ Time Frame: one year after transplant ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.

It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.

The study hypothesis:

Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can

  • reduce relapse rate
  • improve survival

A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Leukemia
Procedure: prophylactic GPBPCI
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
Other Name: modified DLI
Experimental: high-risk leukemia
Intervention: Procedure: prophylactic GPBPCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • high-risk leukemia after HSCT

Exclusion Criteria:

  • active GVHD
  • early relapse
Both
up to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01455272
PUPH IRB [2010] (78)
Yes
Xiaojun Huang, Peking University People's Hospital
Peking University People's Hospital
Not Provided
Principal Investigator: XiaoJun Huang, M.D. Peking University People's Hospital,Institute of Hematology
Peking University People's Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP