Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 9:56 AM
Study NCT ID:
NCT00796068
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2008-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Treosulfan Based Preparative Regimen
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 treosulfan together with fludarabine phosphate and total-body irradiation (TBI) works in treating patients with hematological cancer who are undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CsA) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.
Detailed Description:
PRIMARY OBJECTIVES:
I. Graft failure/rejection and secondary graft failure.
II. Day -200 non-relapse mortality.
SECONDARY OBJECTIVES:
I. Platelet engraftment by six months.
II. Grade II-IV and III-IV acute graft-versus-host disease (GVHD) at day 100 and one year.
III. Chronic GVHD.
IV. Clinically significant infections.
V. Overall survival.
VI. Relapse or disease progression.
VII. Immune reconstitution (Fred Hutchinson Cancer Research Center \[FHCRC\] only).
VIII. Emergence of a dominant unit (FHCRC only).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (low risk for graft failure): Patients receive a conditioning regimen comprising fludarabine phosphate intravenously (IV) over 1 hour once daily (QD) on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo TBI on day -1. Patients then undergo donor UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour or orally (PO) 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD.
ARM II (high risk for graft failure): Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I.
After completion of the study treatment, patients are followed up at 6 months and 1 and 2 years.
I. Graft failure/rejection and secondary graft failure.
II. Day -200 non-relapse mortality.
SECONDARY OBJECTIVES:
I. Platelet engraftment by six months.
II. Grade II-IV and III-IV acute graft-versus-host disease (GVHD) at day 100 and one year.
III. Chronic GVHD.
IV. Clinically significant infections.
V. Overall survival.
VI. Relapse or disease progression.
VII. Immune reconstitution (Fred Hutchinson Cancer Research Center \[FHCRC\] only).
VIII. Emergence of a dominant unit (FHCRC only).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (low risk for graft failure): Patients receive a conditioning regimen comprising fludarabine phosphate intravenously (IV) over 1 hour once daily (QD) on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo TBI on day -1. Patients then undergo donor UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour or orally (PO) 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD.
ARM II (high risk for graft failure): Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I.
After completion of the study treatment, patients are followed up at 6 months and 1 and 2 years.
Study Oversight
Has Oversight DMC:
False
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?: