Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305682
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2006-03-21
Brief Title:
Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as fludarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill cancer cells An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving sirolimus and mycophenolate mofetil after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant sirolimus and mycophenolate mofetil works in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant sirolimus and mycophenolate mofetil works in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the one- and two-year survival of patients with hematologic malignancies treated with a nonmyeloablative conditioning regimen comprising fludarabine cyclophosphamide and total-body irradiation followed by umbilical cord blood transplantation and post-transplant immunosuppression comprising sirolimus and mycophenolate mofetil
Secondary
Determine the six-month nonrelapse mortality of patients treated with this regimen
Determine the presence of chimerism in patients treated with this regimen at days 21 60 100 180 and 365
Determine the incidence of neutrophil engraftment by day 42 in patients treated with this regimen
Determine the incidence of platelet engraftment by six months in patients treated with this regimen
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease GVHD at day 100 in patients treated with this regimen
Determine the incidence of chronic GVHD at one year in patients treated with this regimen
Determine the probability of overall survival within one or two years in patients treated with this regimen
Determine the probability of progression-free survival within one or two years in patients treated with this regimen
Determine the incidence of relapse or disease progression within one or two years in patients treated with this regimen
OUTLINE This is a nonrandomized study Patients are stratified into five disease groups 1 acute myeloid leukemia myelodysplastic syndromes chronic myelogenous leukemia CML in first chronic phase and second chronic phase CP2 after myeloid blast crisis 2 acute lymphoblastic leukemia Burkitts lymphoma CML CP2 post lymphoid blast crisis 3 large-cell B and T-cell lymphoma mantle cell lymphoma 4 chronic lymphocytic leukemiasmall lymphocytic lymphoma prolymphocytic leukemia marginal zone B-cell lymphoma follicular lymphoma 5 Hodgkins lymphoma and multiple myeloma
Nonmyeloablative conditioning Patients receive fludarabine intravenously on days -6 to -2 and cyclophosphamide IV on day -6 Patients who did not undergo prior autologous transplant or who received 1 course of prior multiagent chemotherapy or no severely immunosuppressive therapy in the past 3 months also receive anti-thymocyte globulin IV on days -6 to -4 All patients also undergo total-body irradiation on day -1
Umbilical cord blood transplant Patients undergo umbilical cord blood transplantation on day 0
Post-transplant immunosuppression Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mgday with a target serum concentration of 3 to 12 mgmL Levels are to be monitored 3 timesweek in the first 2 weeks weekly until day 60 and as clinically indicated until day 100 post-transplantation In the absence of acute GVHD sirolimus may be tapered starting at day 100 and eliminated by day 180 post-transplantation Patients also receive mycophenolate mofetil IV on days -3 to 5 and then orally on days 6-30
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 320 patients will be accrued for this study
Primary
Determine the one- and two-year survival of patients with hematologic malignancies treated with a nonmyeloablative conditioning regimen comprising fludarabine cyclophosphamide and total-body irradiation followed by umbilical cord blood transplantation and post-transplant immunosuppression comprising sirolimus and mycophenolate mofetil
Secondary
Determine the six-month nonrelapse mortality of patients treated with this regimen
Determine the presence of chimerism in patients treated with this regimen at days 21 60 100 180 and 365
Determine the incidence of neutrophil engraftment by day 42 in patients treated with this regimen
Determine the incidence of platelet engraftment by six months in patients treated with this regimen
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease GVHD at day 100 in patients treated with this regimen
Determine the incidence of chronic GVHD at one year in patients treated with this regimen
Determine the probability of overall survival within one or two years in patients treated with this regimen
Determine the probability of progression-free survival within one or two years in patients treated with this regimen
Determine the incidence of relapse or disease progression within one or two years in patients treated with this regimen
OUTLINE This is a nonrandomized study Patients are stratified into five disease groups 1 acute myeloid leukemia myelodysplastic syndromes chronic myelogenous leukemia CML in first chronic phase and second chronic phase CP2 after myeloid blast crisis 2 acute lymphoblastic leukemia Burkitts lymphoma CML CP2 post lymphoid blast crisis 3 large-cell B and T-cell lymphoma mantle cell lymphoma 4 chronic lymphocytic leukemiasmall lymphocytic lymphoma prolymphocytic leukemia marginal zone B-cell lymphoma follicular lymphoma 5 Hodgkins lymphoma and multiple myeloma
Nonmyeloablative conditioning Patients receive fludarabine intravenously on days -6 to -2 and cyclophosphamide IV on day -6 Patients who did not undergo prior autologous transplant or who received 1 course of prior multiagent chemotherapy or no severely immunosuppressive therapy in the past 3 months also receive anti-thymocyte globulin IV on days -6 to -4 All patients also undergo total-body irradiation on day -1
Umbilical cord blood transplant Patients undergo umbilical cord blood transplantation on day 0
Post-transplant immunosuppression Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mgday with a target serum concentration of 3 to 12 mgmL Levels are to be monitored 3 timesweek in the first 2 weeks weekly until day 60 and as clinically indicated until day 100 post-transplantation In the absence of acute GVHD sirolimus may be tapered starting at day 100 and eliminated by day 180 post-transplantation Patients also receive mycophenolate mofetil IV on days -3 to 5 and then orally on days 6-30
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 320 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-MT-2005-02 | OTHER | None | None |
| UMN-0507M70121 | OTHER | IRB University of Minnesota | None |