Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013423
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-08-22
Brief Title:
Cord Blood Transplant Cyclophosphamide Fludarabine and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics
Status:
RECRUITING
Status Verified Date:
2024-07
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 II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide fludarabine and total-body irradiation TBI works in treating patients with hematologic diseases Giving chemotherapy such as cyclophosphamide fludarabine and thiotepa and TBI before a donor cord blood transplant CBT helps stop the growth of cancer and abnormal cells and 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 and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases
Detailed Description:
OUTLINE Patients are assigned to 1 of 2 arms
ARM I Patients aged 6 months through 30 years old receive myeloablative conditioning comprising fludarabine intravenously IV over 30 minutes on days -8 to -6 cyclophosphamide IV on days -7 and -6 and undergo high-dose TBI twice daily BID on days -4 to -1 Patients then undergo UCBT on day 0 Patients undergo blood sample collection throughout the study Patients undergo echocardiography ECHO or multigated acquisition scan MUGA and diagnostic imaging during screening and as clinically indicated on study Patients also undergo blood sample collection and bone marrow aspirate during screening and on study
ARM II Patients aged 6 months through 65 years old receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2 cyclophosphamide IV on day -6 thiotepa IV over 2-4 hours on days -5 and -4 and middle-intensity TBI once daily QD on days -2 and -1 Patients undergo ECHO or MUGA and diagnostic imaging during screening and as clinically indicated on study Patients also undergo blood sample collection and bone marrow aspirate during screening and on study
Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours then cyclosporine orally PO if tolerated on days -3 to 100 with taper on day 101 Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO if tolerated three times daily TID on days 8-30 Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD and then tapered over 2-3 weeks beginning on day 45 or 15 days after engraftment if engraftment occurred day 30 after engraftment if there continues to be no evidence of acute GVHD
After completion of study treatment patients are followed up at day 180 1 year and 2 years
ARM I Patients aged 6 months through 30 years old receive myeloablative conditioning comprising fludarabine intravenously IV over 30 minutes on days -8 to -6 cyclophosphamide IV on days -7 and -6 and undergo high-dose TBI twice daily BID on days -4 to -1 Patients then undergo UCBT on day 0 Patients undergo blood sample collection throughout the study Patients undergo echocardiography ECHO or multigated acquisition scan MUGA and diagnostic imaging during screening and as clinically indicated on study Patients also undergo blood sample collection and bone marrow aspirate during screening and on study
ARM II Patients aged 6 months through 65 years old receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2 cyclophosphamide IV on day -6 thiotepa IV over 2-4 hours on days -5 and -4 and middle-intensity TBI once daily QD on days -2 and -1 Patients undergo ECHO or MUGA and diagnostic imaging during screening and as clinically indicated on study Patients also undergo blood sample collection and bone marrow aspirate during screening and on study
Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours then cyclosporine orally PO if tolerated on days -3 to 100 with taper on day 101 Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO if tolerated three times daily TID on days 8-30 Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD and then tapered over 2-3 weeks beginning on day 45 or 15 days after engraftment if engraftment occurred day 30 after engraftment if there continues to be no evidence of acute GVHD
After completion of study treatment patients are followed up at day 180 1 year and 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2023-05598 | REGISTRY | None | None |
| FHIRB0020219 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |