New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
NCT ID: NCT01455272
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2009-07-31
2015-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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high-risk leukemia
prophylactic GPBPCI
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
Interventions
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prophylactic GPBPCI
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* early relapse
60 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiaojun Huang
director of Peking University People's Hospital，Institute of Hematology
Principal Investigators
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XiaoJun Huang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital，Institute of Hematology
Locations
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Lanzhou General Hospital of Lanzhou Command
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Peking University People's Hospital，Institute of Hematology
Beijing, , China
Xinqiao Hospital,Third Military Medical University
Chongqing, , China
Countries
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References
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Yan CH, Wang Y, Sun YQ, Cheng YF, Mo XD, Wang FR, Chen YH, Zhang YY, Han TT, Chen H, Xu LP, Zhang XH, Liu KY, Huang XJ. Optimized therapeutic strategy for patients with refractory or relapsed acute myeloid leukemia: long-term clinical outcomes and health-related quality of life assessment. Cancer Commun (Lond). 2022 Dec;42(12):1387-1402. doi: 10.1002/cac2.12376. Epub 2022 Oct 23.
Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
Yan CH, Liu QF, Wu DP, Zhang X, Xu LP, Zhang XH, Wang Y, Huang H, Bai H, Huang F, Ma X, Huang XJ. Prophylactic Donor Lymphocyte Infusion (DLI) Followed by Minimal Residual Disease and Graft-versus-Host Disease-Guided Multiple DLIs Could Improve Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Refractory/Relapsed Acute Leukemia. Biol Blood Marrow Transplant. 2017 Aug;23(8):1311-1319. doi: 10.1016/j.bbmt.2017.04.028. Epub 2017 May 5.
Other Identifiers
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PUPH IRB [2010] (78)
Identifier Type: -
Identifier Source: org_study_id
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