Reduced Intensity AlloTransplant For Osteopetrosis
|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|
|Primary Completion Date :||May 2008|
|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.
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|