Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00186342|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 17, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Acute Disease Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Myeloproliferative Disorders Blood and Marrow Transplant (BMT) Myelodysplastic Syndromes (MDS) Leukemia||Procedure: ablative allogeneic hematopoietic cell transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide|
|Study Start Date :||September 1992|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: CIK cell
The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.
Procedure: ablative allogeneic hematopoietic cell transplantation
- efficacy of therapy
- compare efficacy of this treatment to historical controls
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|Ages Eligible for Study:||51 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.
2) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
3) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
4) Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186342
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Robert S Negrin||Stanford University|
|Responsible Party:||Robert Negrin, Professor of Lymphatic Research and Medicine, Stanford University|
|Other Study ID Numbers:||
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||December 17, 2012|
|Last Verified:||December 2012|
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases
Neoplasms by Site