Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors
This study has been completed.
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186225
First received: September 13, 2005
Last updated: July 23, 2010
Last verified: July 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | July 23, 2010 | ||||
| Start Date ICMJE | November 1989 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors. [ Time Frame: unknown ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Toxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors. | ||||
| Change History | Complete list of historical versions of study NCT00186225 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors | ||||
| Official Title ICMJE | Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY) | ||||
| Brief Summary | To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies. |
||||
| Detailed Description | Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor. |
||||
| 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 |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: ablative allogeneic hematopoietic cell transplantation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:- acute leukemia
Exclusion Criteria:- organ dysfunction - HIV positive |
||||
| 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 | NCT00186225 | ||||
| Other Study ID Numbers ICMJE | BMT22, 75268, BMT22 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Laura Johnston, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Stanford University | ||||
| Verification Date | July 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||