Reduced Intensity AlloTransplant For Osteopetrosis
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|ClinicalTrials.gov Identifier: NCT00638820|
Recruitment Status : Terminated (Excess toxicity)
First Posted : March 19, 2008
Results First Posted : February 3, 2010
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteopetrosis||Procedure: Stem Cell or Umbilical Cord Blood Transplantation Drug: Campath, Busulfan, Clofarabine Procedure: Total Lymphoid Irradiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduced Intensity Allogeneic Transplantation For Severe Osteopetrosis Incorporating A Second Cd34 Selected Graft|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Patients enrolled and received study treatment.
Procedure: Stem Cell or Umbilical Cord Blood Transplantation
Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42
Other Name: Bone Marrow TransplantDrug: Campath, Busulfan, Clofarabine
Other Name: Busulfex, Clolar,AlemtuzumabProcedure: Total Lymphoid Irradiation
Dose 500 cGy via anteroposterior (AP) and posteroanterior (PA) fields (250 cGy AP and 250 cGy PA).
Other Name: Therapuetic radation, radiation therapy
- Number of Patients Achieving Donor Cell Engraftment [ Time Frame: Day 100 ]Number of patients with persistent presence of donor-derived cells at Day 100
- Number of Patients With Transplant Related Death [ Time Frame: Day 100 ]Number of participants died during study by Day 100 and reason for death was related to transplant.
- Number of Patients With Transplant Related Toxicity [ Time Frame: Day 100 ]Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0.
- Differential Imaging and Biologic Evaluations [ Time Frame: Day 100, 6 months, 1, 2 and 5 years ]These outcome measures were not assessed due to early study termination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638820
|United States, Minnesota|
|University of MInnesota, Fairview|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Paul Orchard, MD||Masonic Cancer Center, University of Minnesota|