Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)
This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)|
- To determine the treatment-related mortality rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens within 1st 100-days. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
- To determine the engraftment rate of allogeneic stem cell transplants [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens.
To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Drug: Regimen A
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139164
|Contact: Jessica Simons||(843) firstname.lastname@example.org|
|Contact: Amy Johnson, CCRP||(843)email@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Karen Rogers 843-792-2740 firstname.lastname@example.org|
|Principal Investigator: Robert Stuart, MD|
|Principal Investigator:||Robert Stuart, MD||Medical University of South Carolina|