Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354172
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2006-07-19
Brief Title:
Donor Umbilical Cord Blood Natural Killer Cells Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With CyclophosphamideFludarabineTotal Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Competing study was started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy natural killer cells aldesleukin and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells and cancer cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving cyclosporine mycophenolate mofetil and methylprednisolone before and after transplant may stop this from happening
PURPOSE This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by donor umbilical cord blood natural killer cells aldesleukin and umbilical cord blood transplant works in treating patients with refractory hematologic cancer or other diseases
PURPOSE This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by donor umbilical cord blood natural killer cells aldesleukin and umbilical cord blood transplant works in treating patients with refractory hematologic cancer or other diseases
Detailed Description:
OBJECTIVES
Primary
Determine the incidence of 6-month disease free survival The primary laboratory objective is the measure of in vivo expansion of umbilical cord blood UCB derived natural killer cells NK after a fully ablative preparative regimen
Secondary
Determine the incidence of transplant-related mortality at 6 months after NK UCB double UCBT
Evaluate the pattern of chimerism after NK UCB double UCBT
Determine the incidence of neutrophil engraftment at day 42 after NK UCB double umbilical cord blood transplantation UCBT
Determine the incidence of platelet engraftment at 6 months after NK UCB double UCBT
Determine the incidence of acute graft-versus-host disease GVHD grade II-IV and grade III-IV at day 100 after NK UCB double UCBT
Determine the incidence of chronic GVHD at 1 year after NK UCB double UCBT
Determine the disease-free survival at 1 after NK UCB double UCBT
Determine the incidence of relapse at 1 after NK UCB double UCBT
OUTLINE This is a single arm nonrandomized open-label study
Myeloablative conditioning regimen Patients receive fludarabine intravenously IV over 1 hour on days -18 to -16 and cyclophosphamide intravenously IV on days -18 and -17 Patients undergo total-body irradiation twice daily on days -16 to -13
Haploidentical umbilical cord blood UCB natural killer NK cell therapy and aldesleukin Patients undergo haploidentical UCB-enriched NK cell CD3- depleted infusion on day -13 Patients then receive aldesleukin subcutaneously on days -13 -11 -9 -7 -5 and -3 Some patients may also receive methylprednisolone IV on days -1 and 0
UCB transplantation UCBT Patients undergo a single or double UCBT on day 0 Beginning on day 1 patients receive filgrastim G-CSF IV once daily until blood counts recover
Graft-vs-host disease GVHD prophylaxis Patients receive cyclosporine IV over 2 hours 2-3 times daily beginning on day -1 and continuing until day 100 followed by a taper until day 180 Patients also receive mycophenolate mofetil IV or orally 2-3 times daily beginning on day -1 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD
Primary
Determine the incidence of 6-month disease free survival The primary laboratory objective is the measure of in vivo expansion of umbilical cord blood UCB derived natural killer cells NK after a fully ablative preparative regimen
Secondary
Determine the incidence of transplant-related mortality at 6 months after NK UCB double UCBT
Evaluate the pattern of chimerism after NK UCB double UCBT
Determine the incidence of neutrophil engraftment at day 42 after NK UCB double umbilical cord blood transplantation UCBT
Determine the incidence of platelet engraftment at 6 months after NK UCB double UCBT
Determine the incidence of acute graft-versus-host disease GVHD grade II-IV and grade III-IV at day 100 after NK UCB double UCBT
Determine the incidence of chronic GVHD at 1 year after NK UCB double UCBT
Determine the disease-free survival at 1 after NK UCB double UCBT
Determine the incidence of relapse at 1 after NK UCB double UCBT
OUTLINE This is a single arm nonrandomized open-label study
Myeloablative conditioning regimen Patients receive fludarabine intravenously IV over 1 hour on days -18 to -16 and cyclophosphamide intravenously IV on days -18 and -17 Patients undergo total-body irradiation twice daily on days -16 to -13
Haploidentical umbilical cord blood UCB natural killer NK cell therapy and aldesleukin Patients undergo haploidentical UCB-enriched NK cell CD3- depleted infusion on day -13 Patients then receive aldesleukin subcutaneously on days -13 -11 -9 -7 -5 and -3 Some patients may also receive methylprednisolone IV on days -1 and 0
UCB transplantation UCBT Patients undergo a single or double UCBT on day 0 Beginning on day 1 patients receive filgrastim G-CSF IV once daily until blood counts recover
Graft-vs-host disease GVHD prophylaxis Patients receive cyclosporine IV over 2 hours 2-3 times daily beginning on day -1 and continuing until day 100 followed by a taper until day 180 Patients also receive mycophenolate mofetil IV or orally 2-3 times daily beginning on day -1 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD
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 |
|---|---|---|---|
| 0509M73449 | OTHER | IRB University of Minnesota | None |
| MT2005-18 | OTHER | None | None |