Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008151
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2001-01-06
Brief Title:
Gemtuzumab Ozogamicin Fludarabine and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Gemtuzumab Ozogamicin GO Fludarabine And Low-Dose TBI Followed By Donor Stem Cell Transplantation For Patients With Advanced Acute Myeloid Leukemia Or Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2010-03
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 Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the response and disease-free survival at 1 year of patients with advanced acute myeloid leukemia or myelodysplastic syndrome treated with gemtuzumab ozogamicin fludarabine and total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation with cyclosporine and mycophenolate mofetil II Determine the leukemic blast clearance from the blood and marrow in these patients treated with this regimen III Determine the safety and pharmacokinetics of gemtuzumab ozogamicin as part of this regimen in these patients IV Determine the incidence of donor stem cell engraftment in these patients V Determine the incidence and severity of graft-versus-host disease in these patients treated with this regimen VI Determine whether donor lymphocyte infusion can be safely used in the patients with mixed or full donor chimerism to eliminate persistent or progressive disease
OUTLINE Patients receive gemtuzumab ozogamicin IV over 2 hours on days -21 first 5 patients or -14 subsequent patients and -7 and fludarabine IV over 2 hours on days -4 to -2 Patients undergo total body irradiation followed by infusion of allogeneic peripheral blood stem cells or bone marrow on day 0 Patients receive oral or IV cyclosporine 2-3 times daily on days -3 to 56 if related donor or 100 if unrelated donor and oral or IV mycophenolate mofetil twice daily on days 0 to 27 if related donor or 40 if unrelated donor Patients receive 2 doses of intrathecal methotrexate prior to transplant and an additional 4 doses after transplant Patients with cerebral spinal fluid CSF positive for malignant cells instead receive intrathecal cytarabine methotrexate and hydrocortisone prior to transplant twice weekly until CSF blasts clear Patients with persistent or recurrent disease after transplant may receive up to 3 donor lymphocyte infusions if graft-versus-host disease is less than grade II and they have greater than 5 donor CD3 cells Patients are followed at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 1-2 years
OUTLINE Patients receive gemtuzumab ozogamicin IV over 2 hours on days -21 first 5 patients or -14 subsequent patients and -7 and fludarabine IV over 2 hours on days -4 to -2 Patients undergo total body irradiation followed by infusion of allogeneic peripheral blood stem cells or bone marrow on day 0 Patients receive oral or IV cyclosporine 2-3 times daily on days -3 to 56 if related donor or 100 if unrelated donor and oral or IV mycophenolate mofetil twice daily on days 0 to 27 if related donor or 40 if unrelated donor Patients receive 2 doses of intrathecal methotrexate prior to transplant and an additional 4 doses after transplant Patients with cerebral spinal fluid CSF positive for malignant cells instead receive intrathecal cytarabine methotrexate and hydrocortisone prior to transplant twice weekly until CSF blasts clear Patients with persistent or recurrent disease after transplant may receive up to 3 donor lymphocyte infusions if graft-versus-host disease is less than grade II and they have greater than 5 donor CD3 cells Patients are followed at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| CDR0000068383 | REGISTRY | PDQ | None |
| FHCRC-155500 | None | None | None |
| NCI-G00-1900 | None | None | None |