A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy
In this study two cord blood collections will be used to increase the number of cord blood cells you will receive on transplant day. We call this a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplant may have a better result. The main purpose of this study is to find out how good a cord blood transplant using two cord blood collections from two different babies is at curing you of your cancer. Double unit cord blood transplants are now being studied as a way to increase the number of cord blood cells given to bigger children and adult patients.
Based on studies that have already been done double unit cord blood transplant appears to be safer than if only one cord blood unit is used. However, double unit cord blood transplant is a fairly new form of treatment.
Drug: Fludarabine, Cyclophosphamide
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Myeloablative Conditioning Regimen Consisting of Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients With Hematological Malignancy.|
- To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall and disease-free survival at 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The incidence and rate of donor derived neutrophil and platelet recovery; the contribution of each unit to initial and sustained engraftment; the incidence and severity of acute GVHD at 100 days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Patients with hematopoietic malignancy at high-risk for relapse or with advanced disease will receive myeloablative conditioning with cyclophosphamide (Cy), low dose fludarabine (Flu) and total body irradiation (TBI) with post transplantation cyclosporine (CSA) and mycophenolate mofetil (MMF) for GVHD prophylaxis.
Drug: Fludarabine, Cyclophosphamide
Fludarabine 25 mg/m2/day IV in the morning x 3 days (days -7, -6 and -5) for a total dose of 75 mg/m2 followed by Cyclophosphamide on days -6 and -5. 60mg/kg/day IV over 30-60 minutes x 2 days (days -6 and -5). High volume fluids should commence approximately 12 hours prior to drug and continue until 24 hours after second dose.
Total Body Irradiation: 125 cGy x 11 doses (TID on days -3, -2, -1 and BID on day 0) for a total TBI dose of 1375 cGy. Pediatric patients unable to tolerate a TID dosing schedule can receive 150 cGy x 8 doses (BID on days -3, -2, -1, and 0). All patients will receive GVHD prophylaxis with 2 drugs: Cyclosporine A and Mycophenolate mofetil (MMF).
Units should be given consecutively each over approximately 10-30 minutes.Pre-medication should include acetaminophen and diphenhydramine or hydroxyzine.G-CSF 5 mcg/kg/day IV/SQ (dose rounded to vial size to a maximum of 480 mcg) will be given from day +1 until ANC recovery.
The UCB ( Umbilical Cord Blood) collection known as a unit is processed to remove excess plasma and red cells, tested for sterility, HLA-typed, cryopreserved and stored. This protocol involves the administration of two UCB units from two different donors. The units will be thawed in the Cytotherapy Laboratory as per the current standard operating procedure.
This is a single arm phase 2 study to obtain a preliminary estimate of efficacy of myeloablative double unit umbilical cord blood transplantation (UCBT) as measured by overall and disease-free survival at 1 year post transplantation. The UCB graft will consist of two (or double) units from two unrelated newborn donors. Patients with hematopoietic malignancy at high-risk for relapse or with advanced disease will receive myeloablative conditioning with cyclophosphamide (Cy),low dose fludarabine (Flu) and total body irradiation (TBI) with post transplantation cyclosporine (CSA) and mycophenolate mofetil (MMF) for GVHD prophylaxis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597519
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Juliet Barker, MBBS||Memorial Sloan Kettering Cancer Center|