Allo BMT in Advanced Leukemia or High Grade Lymphoma
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 7, 2010 | ||||
| Start Date ICMJE | December 1989 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00186290 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
early and late toxicities of the treatment regimen [ Time Frame: October 2009 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
early and late toxicities of the treatment regimen | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Allo BMT in Advanced Leukemia or High Grade Lymphoma | ||||
| Official Title ICMJE | Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients With Advanced Leukemia or High Grade Lymphoma | ||||
| Brief Summary | To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma. |
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| Detailed Description | To determine the disease free survival and overall survival of patients with ALL and ANLL after induction failure, in relapse, or subsequent remission from CML in several phases or recurrent lymphoblastic lymphoma who receive fractionated TBI, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients with Advanced Leukemia or High Grade Lymphoma |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: ablative allogeneic hematopoietic cell transplantation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 145 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:HLA identical donor
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| Gender | Both | ||||
| Ages | up to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00186290 | ||||
| Other Study ID Numbers ICMJE | BMT34, 74165, BMT34 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Robert Lowsky, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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