Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
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ClinicalTrials.gov Identifier: NCT00975975 |
Recruitment Status
:
Completed
First Posted
: September 14, 2009
Results First Posted
: February 26, 2016
Last Update Posted
: February 26, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | September 11, 2009 | |||
First Posted Date ICMJE | September 14, 2009 | |||
Results First Submitted Date | January 28, 2016 | |||
Results First Posted Date | February 26, 2016 | |||
Last Update Posted Date | February 26, 2016 | |||
Study Start Date ICMJE | September 2009 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Grade 3-4 Acute GVHD Rate [ Time Frame: Transplant (Day 0) up to 1 year ] The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
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Original Primary Outcome Measures ICMJE |
Assess the incidence grade 3-4 aGVHD; Compare the incidence of grade 3-4 aGVHD with those of a recently completed clinical trial cohort [ Time Frame: Pre-Transplant thru 1 year post transplant ] | |||
Change History | Complete list of historical versions of study NCT00975975 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To test the hypothesis that donor cell engraftment is associated with an expansion of donor-derived natural killer cells in the immediate post-transplant period [ Time Frame: Pre-transplant thru 1 year post-transplant ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer | |||
Official Title ICMJE | Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer | |||
Brief Summary | The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues. | |||
Detailed Description | This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition. This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Basiliximab
Basiliximab given 1 time on Day +7 or Day +9.
Other Name: Simulect |
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Study Arms | Experimental: Basiliximab
Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.
Intervention: Drug: Basiliximab |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
17 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00975975 | |||
Other Study ID Numbers ICMJE | 0908-04; IUCRO-0256 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Indiana University ( Indiana University School of Medicine ) | |||
Study Sponsor ICMJE | Indiana University School of Medicine | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Indiana University | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |