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New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation

This study has been completed.
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital Identifier:
First received: October 12, 2011
Last updated: April 5, 2015
Last verified: April 2015

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

Condition Intervention
Procedure: prophylactic GPBPCI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia

Resource links provided by NLM:

Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • relapse rate [ Time Frame: one year after HSCT ]

Secondary Outcome Measures:
  • survival probability [ Time Frame: one year after transplant ]

Estimated Enrollment: 100
Study Start Date: July 2009
Study Completion Date: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high-risk 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

Detailed Description:
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.

Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • high-risk leukemia after HSCT

Exclusion Criteria:

  • active GVHD
  • early relapse
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Please refer to this study by its identifier: NCT01455272

China, Gansu
Lanzhou General Hospital of Lanzhou Command
Lanzhou, Gansu, China
China, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
China, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Peking University People's Hospital,Institute of Hematology
Beijing, China, 100044
Xinqiao Hospital,Third Military Medical University
Chongqing, China
Sponsors and Collaborators
Peking University People's Hospital
Principal Investigator: XiaoJun Huang, M.D. Peking University People's Hospital,Institute of Hematology
  More Information

Responsible Party: Xiaojun Huang, director of Peking University People's Hospital,Institute of Hematology, Peking University People's Hospital Identifier: NCT01455272     History of Changes
Other Study ID Numbers: PUPH IRB [2010] (78)
Study First Received: October 12, 2011
Last Updated: April 5, 2015

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2017