NCT00597714|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
264
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
November 2013
Actual (reported)The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2008
Actual (reported)January 18, 2008
Actual (reported)February 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 2013
Actual (reported)November 2013
Actual (reported)June 2, 2014
Actual (reported)Disease Free Survival
Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.
2 years
Immune Recovery
1 year
Group A: Patients with a high chance of progressive lymphoid or myelomatous disease undergo Non-myeloablative Stem Cell Transplantation.
Group B: Patients with a high chance of progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders undergo Non-myeloablative Stem Cell Transplantation.
The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. Group B's prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Patient evaluations will occur 2 times per week by physical exam for toxicity through day 45.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke University Health System
Durham, North Carolina, 27710, United States
Kanda J, Long GD, Gasparetto C, Horwitz ME, Sullivan KM, Chute JP, Morris A, Shafique M, Li Z, Chao NJ, Rizzieri DA. Reduced-intensity allogeneic transplantation using alemtuzumab from HLA-matched related, unrelated, or haploidentical related donors for patients with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Feb;20(2):257-63. doi: 10.1016/j.bbmt.2013.11.010. Epub 2013 Nov 20.
David Rizzieri, MD
Duke Health
264 participants (actual enrollment reported by the registry).
First Submitted
January 14, 2008
First Posted
January 18, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Progression Free Survival
2 years
Overall Survival
2 years
Graft Failure
180 days
Graft Versus Host Disease
180 days
Donor priming and apheresis will include filgrastim 8 mcg/kg subcutaneously twice daily for 4 days prior to stem cell collection and continuing until pheresis is completed. Alternative mobilization strategies may be employed at the investigator's discretion.
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
June 2, 2014
Results First Posted
June 2, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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