Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01962636|
Recruitment Status : Recruiting
First Posted : October 14, 2013
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Chronic Myelogenous Leukemia Plasma Cell Leukemia Myelofibrosis Myelodysplasia Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Marginal Zone B-Cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle-Cell Lymphoma Prolymphocytic Leukemia Diffuse Large B Cell Lymphoma Lymphoblastic Lymphoma Burkitt's Lymphoma Non-Hodgkin Lymphoma Multiple Myeloma||Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total Body Irradiation Drug: Cyclosporine A Drug: Mycophenylate mofetil Biological: Umbilical cord blood||Not Applicable|
This is a study to collect routine clinical data from UCBT using unrelated single or double UCB units as an alternative, non-HLA-matched stem cell source for patients with hematological diseases.
- data collection from transplant preparative therapy consisting of treatments with chemotherapeutic regimens and total body irradiation.
- data collection from umbilical cord blood selection and infusion.
- data collection from standard supportive disease and transplant related care.
Pre- and post-transplant medication, UCB selection and infusion, supportive care, and follow-up will be according to the current University of Minnesota BMT guidelines.
An average of 18 patients are expected to be treated on this protocol per year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Umbilical Cord Blood Transplant
The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI)followed by umbilical cord blood transplant. Immunosuppressive Cyclosporine and Mycophenylate Mofetil (MMF) will be administered pre- and post UCBT.
25 mg/m^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.
Other Name: Fludara
60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.
Other Name: Cytoxan
Radiation: Total Body Irradiation
165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.
Drug: Cyclosporine A
Cyclosporine A (CSA) will start day -3 and will be administered PO/IV maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
Other Name: CSA
Drug: Mycophenylate mofetil
Mycophenylate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3.
Other Name: MMF
Biological: Umbilical cord blood
Pre-medications and UCB infusion will be per current institutional policies/guidelines. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. If 2 units are used, both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending or designee.
Other Name: UCB
- Survival at 1 year post-transplant [ Time Frame: 1 year ]The number of patients that are still living 1 year after UCBT.
- Incidence of neutrophil engraftment at day 42. [ Time Frame: 42 days ]Number of subjects with neutrophil engraftment at day 42 post UCBT.
- Platelet engraftment at 1 year. [ Time Frame: 1 year ]Number of patients with platelet engraftment at 1 year post UCBT.
- Pattern of chimerism after transplant. [ Time Frame: 1 year ]Pattern of chimerism after transplant. Chimerism will be plotted with box-plots and described over time.
- Incidence of graft failure. [ Time Frame: 100 days ]Cumulative incidence of graft failure after UCBT.
- Incidence of acute graft versus host disease at 100 days. [ Time Frame: 100 days ]Cumulative incidence will be used to estimate acute graft versus host disease 100 days after UCBT.
- Incidence of chronic graft versus host disease at 1 year. [ Time Frame: 1 year ]Cumulative incidence will be used to estimate chronic GVHD at 1 year post UCBT.
- Incidence of transplant related mortality at 6 months. [ Time Frame: 6 months ]Cumulative incidence will be used to estimate transplant related mortality at 6 months post UCBT.
- Incidence of disease free survival [ Time Frame: 1, 2 years ]Kaplan-Meier curves will be used to estimate disease-free survival at 1 and 2 years post UCBT.
- Incidence of overall survival. [ Time Frame: 1, 2 years ]Kaplan-Meier curves will be used to estimate overall survival at 1 and 2 years post UCBT.
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): NCT01962636
|Contact: Claudio Brunstein, MDfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota Masonic Cancer Center||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Claudio Brunstein, MD 612-625-3918 email@example.com|
|Principal Investigator: Claudio Brunstein, MD|
|Principal Investigator:||Claudio Brunstein, MD||University of Minnesota - Clinical and Translational Science Institute|