New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
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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 |
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (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 |
Inclusion Criteria:
- high-risk leukemia after HSCT
Exclusion Criteria:
- active GVHD
- early relapse
Contacts and Locations| Contact: Yu Wang, M.D. | 8610 88326666 ext 4952 | ywyw31720@yahoo.com.cn |
| China, Gansu | |
| Lanzhou General Hospital of Lanzhou Command | Recruiting |
| Lanzhou, Gansu, China | |
| Contact: Rui Si xirui36@tom.com | |
| China, Guangdong | |
| Nanfang Hospital, Southern Medical University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Meiqing Wu, Ph.D wumeiqing1309@163.com | |
| China, Jiangsu | |
| The First Affiliated Hospital of Soochow University | Recruiting |
| Suzhou, Jiangsu, China | |
| Contact: Xiaowen Tang xwtang1020@163.com | |
| China, Zhejiang | |
| The First Affiliated Hospital of Medical School of Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Yi Luo luoyijr@163.com | |
| China | |
| Peking University People's Hospital，Institute of Hematology | Recruiting |
| Beijing, China, 100044 | |
| Contact: Yu Wang ywyw31720@yahoo.com.cn | |
| Xinqiao Hospital,Third Military Medical University | Recruiting |
| Chongqing, China | |
| Contact: Li Gao gaotiantiantiger@163.com | |
| 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: | May 15, 2013 |
| 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 June 17, 2013