Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005622
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2000-05-02
Brief Title:
Donor Bone Marrow Transplant in Treating Patients With Leukemia Lymphoma or Nonmalignant Hematologic Disorders
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
Status:
COMPLETED
Status Verified Date:
2012-10
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 Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells When the stem cells from a related or unrelated donor that closely matches the patients blood are infused into the patient they may help the patients bone marrow to make stem cells red blood cells white blood cells and platelets
PURPOSE This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia lymphoma or nonmalignant hematologic disorders
PURPOSE This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia lymphoma or nonmalignant hematologic disorders
Detailed Description:
OBJECTIVES
Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders
Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients
Determine the relapse rates with this treatment regimen in those patients with malignant disorders
Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients
OUTLINE Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 total body radiotherapy on days -3 through 0 and allogeneic bone marrow transplantation on day 0
Patients with acute lymphocytic leukemia ALL receive intrathecal methotrexate at the beginning of the study If CNS involvement is documented patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses Patients with ALL andor CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant
Patients with prior CNS involvement receive radiotherapy for 25 weeks prior to transplant Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant
Patients are followed once a week for 3 months and then monthly for 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 6 years
Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders
Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients
Determine the relapse rates with this treatment regimen in those patients with malignant disorders
Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients
OUTLINE Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 total body radiotherapy on days -3 through 0 and allogeneic bone marrow transplantation on day 0
Patients with acute lymphocytic leukemia ALL receive intrathecal methotrexate at the beginning of the study If CNS involvement is documented patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses Patients with ALL andor CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant
Patients with prior CNS involvement receive radiotherapy for 25 weeks prior to transplant Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant
Patients are followed once a week for 3 months and then monthly for 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 6 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-G00-1755 | OTHER | NCI | None |
| IRB-4189 | OTHER | None | None |