Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343798
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2006-06-22
Brief Title:
A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Pilot Study to Evaluate the Co-infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine cyclophosphamide and total body irradiation TBI and immunosuppression with cyclosporine and mycophenolate mofetil MMF for patients with hematologic malignancies Chemotherapy such as fludarabine and cyclophosphamide and TBI given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patients immune system from rejecting the donors stem cells The healthy stem cells from the donors umbilical cord blood help the patients bone marrow make new red blood cells white blood cells and platelets It may take several weeks for these new blood cells to grow During that period of time patients are at increased risk for bleeding and infection Faster recovery of white blood cells may decrease the number and severity of infections Studies have shown that counts are more likely to recover more quickly if increased numbers of cord blood cells are given with the transplant We have developed a way of growing or expanding the number of cord blood cells in the lab so that there are more cells available for transplant We are doing this study to find out whether or not giving these expanded cells along with one unexpanded cord blood unit is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant We will study the time it takes for blood counts to recover which of the two cord blood units makes up the patients new blood system and how quickly immune system cells return
Detailed Description:
PRIMARY OBJECTIVES
I Examine the safety and toxicity when ex vivo expanded cord blood cells are co-infused with a second non-human leukocyte antigen HLA-identical cord blood graft following myeloablative therapy in patients with hematologic malignancies
II Examine the in vivo persistence of the ex vivo expanded cord blood cells The kinetics and durability of hematopoietic reconstitution time to engraftment defined as the first of 2 consecutive days in which the absolute neutrophil count ANC 500 will be determined and the relative contribution to engraftment of the expanded cord blood cells and the unmanipulated cord blood cells in early and long-term engraftment will be determined by donor chimerisms
SECONDARY OBJECTIVES
I Estimate the incidence and severity of acute and chronic graft-versus-host disease GVHD in patients receiving Notch-expanded cord blood cells
II Estimate the incidence of transplant related mortality at day 100
III Estimate the incidence of malignant relapse and probabilities of overall and event-free survival at 1 and 2 years post transplant
IV Obtain preliminary data on the phenotype and function of immune cells recovering in patients receiving expanded and unmanipulated cord blood grafts
V Obtain feasibility data on overnight shipment of ex vivo expanded progenitor cells for infusion in patients are distant sites
OUTLINE
MYELOABLATIVE CONDITIONING REGIMEN Patients receive fludarabine intravenously IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6 Patients undergo TBI twice daily BID on days -4 to -1
TRANSPLANTATION On Day 0 patients undergo double-unit umbilical cord blood transplantation which includes the infusion of one unmanipulated not expanded cord blood unit followed 4 hours later by infusion of one ex vivo-expanded cord blood unit
GRAFT-VERSUS-HOST-DISEASE PROPHYLAXIS Patients initially receive cyclosporine IV beginning on day -3 Cyclosporine may be given orally when the patient can tolerate oral medications and has a normal gastrointestinal transit time Cyclosporine is given until day 100 and may taper on day 101 if there is no graft versus host disease Patients also receive MMF IV on days -3 to 5 and then may receive oral MMF beginning day 6 to 30 MMF is stopped at Day 30 or 7 days after engraftment whichever day is later if no acute GVHD
After completion of study treatment patients are followed up periodically for 2 years
I Examine the safety and toxicity when ex vivo expanded cord blood cells are co-infused with a second non-human leukocyte antigen HLA-identical cord blood graft following myeloablative therapy in patients with hematologic malignancies
II Examine the in vivo persistence of the ex vivo expanded cord blood cells The kinetics and durability of hematopoietic reconstitution time to engraftment defined as the first of 2 consecutive days in which the absolute neutrophil count ANC 500 will be determined and the relative contribution to engraftment of the expanded cord blood cells and the unmanipulated cord blood cells in early and long-term engraftment will be determined by donor chimerisms
SECONDARY OBJECTIVES
I Estimate the incidence and severity of acute and chronic graft-versus-host disease GVHD in patients receiving Notch-expanded cord blood cells
II Estimate the incidence of transplant related mortality at day 100
III Estimate the incidence of malignant relapse and probabilities of overall and event-free survival at 1 and 2 years post transplant
IV Obtain preliminary data on the phenotype and function of immune cells recovering in patients receiving expanded and unmanipulated cord blood grafts
V Obtain feasibility data on overnight shipment of ex vivo expanded progenitor cells for infusion in patients are distant sites
OUTLINE
MYELOABLATIVE CONDITIONING REGIMEN Patients receive fludarabine intravenously IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6 Patients undergo TBI twice daily BID on days -4 to -1
TRANSPLANTATION On Day 0 patients undergo double-unit umbilical cord blood transplantation which includes the infusion of one unmanipulated not expanded cord blood unit followed 4 hours later by infusion of one ex vivo-expanded cord blood unit
GRAFT-VERSUS-HOST-DISEASE PROPHYLAXIS Patients initially receive cyclosporine IV beginning on day -3 Cyclosporine may be given orally when the patient can tolerate oral medications and has a normal gastrointestinal transit time Cyclosporine is given until day 100 and may taper on day 101 if there is no graft versus host disease Patients also receive MMF IV on days -3 to 5 and then may receive oral MMF beginning day 6 to 30 MMF is stopped at Day 30 or 7 days after engraftment whichever day is later if no acute GVHD
After completion of study treatment patients are followed up periodically for 2 years
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 |
|---|---|---|---|
| NCI-2010-00236 | REGISTRY | None | None |
| R43HL106868 | NIH | None | None |
| R24HL074445 | NIH | None | None |
| RC2HL101844 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchRC2HL101844 |