NCT00004143|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
OTHER · Duke University Medical Center Institutional Review Board
OTHER_GRANT · National Cancer Institute
interventional
2
1 country
2
Study Start
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
June 2009
Actual (reported)RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-cancerous conditions, the risks of this procedure outweigh the potential benefits. This protocol is designed to test a new approach to allogeneic stem cell transplantation. It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
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.
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
December 10, 1999
Actual (reported)January 27, 2003
Actual (reported)May 2008
Actual (reported)June 2009
Actual (reported)November 11, 2013
Actual (reported)Number of Patients With Neutrophil Engraftment
Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) \> 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity \< 5%, peripheral White Blood Count (WBC) \< 500/μL, peripheral ANC \< 100/μL, and/or platelets \< 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).
1 year post transplant
Number of Patients With Platelet Engraftment
Number of patients with platelet engraftment - Platelets \> 20,000/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity \< 5%, peripheral White Blood Count (WBC) \< 500/μL, peripheral ANC \< 100/μL, and/or platelets \< 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).
Campath, Chemo and/or TBI Allo SCT
Campath, Chemo and/or TBI Allo SCT
Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Small number of subjects analyzed
David A. Rizzieri, MD
Duke Cancer Institute
Mitchell Horwitz, MD
Duke University
2 participants (actual enrollment reported by the registry).
First Submitted
December 10, 1999
First Posted
January 27, 2003
Study Start
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
1 year post transplant
Number of Patients With Grade 3-4 Acute Graft Versus Host Disease (GVHD)
Number of patients with Grade 3-4 acute Graft Versus Host Disease (GVHD). GVHD will be monitored at least two times per week through day 45, then weekly through day 60 and graded by 2 persons at each institution, to ensure internal consistency in grading.
60 days post transplant
Number of Participants With Grade 3-4 Unexpected Adverse Events
An unexpected adverse event is one that differs in the nature, severity, or frequency from (a) the research procedures that are described in the protocol-related documents, (such as the IRB-approved research protocol and informed consent document) as expected, and/or (b) the characteristics of the subject population being studied.
45 days post transplant
Number of Participants With Transplant-related Mortality
Number of patients who died due to transplant-related complications
100 days
Overall Survival
2 years
Contact the study team to confirm eligibility.
Primary Completion
May 2008
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
December 5, 2014
Results First Posted
November 11, 2013
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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