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
  Purpose

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
Leukemia
Procedure: prophylactic GPBPCI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival probability [ Time Frame: one year after transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: January 2015
Primary Completion Date: January 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.

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high-risk leukemia after HSCT

Exclusion Criteria:

  • active GVHD
  • early relapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455272

Locations
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
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
Investigators
Principal Investigator: XiaoJun Huang, M.D. Peking University People's Hospital,Institute of Hematology
  More Information

No publications provided

Responsible Party: Xiaojun Huang, director of Peking University People's Hospital,Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01455272     History of Changes
Other Study ID Numbers: PUPH IRB [2010] (78)
Study First Received: October 12, 2011
Last Updated: March 24, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014