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| Tracking Information | |||||
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| First Received Date ICMJE | February 5, 2003 | ||||
| Last Updated Date | May 30, 2009 | ||||
| Start Date ICMJE | November 2000 | ||||
| Estimated Primary Completion Date | December 2010 (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 NCT00054327 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Graft-versus-host disease measured weekly [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Graft-versus-host disease measured weekly | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer | ||||
| Official Title ICMJE | Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors | ||||
| Brief Summary | RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive 1 of the following preparative regimens:
All patients undergo stem cell transplantation from a matched, unrelated donor on day 0. Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: Not specified |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | up to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00054327 | ||||
| Responsible Party | Susan Wiersma, Case Comprehensive Cancer Center | ||||
| Study ID Numbers ICMJE | CDR0000270380, CASE-CWRU-1Y00, CASE-1Y00 | ||||
| Study Sponsor ICMJE | Case Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2009 | ||||
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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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