Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003187
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2000-05-02
Brief Title:
Bone Marrow Transplantation in Treating Patients With Leukemia Myelodysplasia or Lymphoblastic Lymphoma
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
The Unrelated Donor Marrow Transplantation Trial
Status:
COMPLETED
Status Verified Date:
2010-02
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:
RATIONALE Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Eliminating the T cells from the donor cells before transplanting them may prevent this from happening
PURPOSE Randomized phase IIIII trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia myelodysplasia or lymphoblastic lymphoma
PURPOSE Randomized phase IIIII trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia myelodysplasia or lymphoblastic lymphoma
Detailed Description:
OBJECTIVES I Compare the disease free survival of patients with leukemia myelodysplasia or lymphoblastic lymphoma after treatment with conventional non-T cell depleted or T cell depleted unrelated donor bone marrow transplantation II Compare the incidence of primary and secondary graft failure acute and chronic graft-vs-host disease complications infection veno-occlusive disease interstitial pneumonitis and relapse in these patients after these treatments III Compare the incidence of other malignancies lymphoproliferative disorders and post-transplant myelodysplasia in these patients after these treatments
OUTLINE This is a randomized multicenter study Patients will be stratified according to institution Patients are assigned to one of two treatment arms one with conventional bone marrow transplantation arm I and one with T cell depletion of the bone marrow arm II Arm I Patients receive cyclophosphamide on days -6 and -5 Total body irradiation TBI is administered on days -4 to 0 although this order may be reversed Males with ALL receive a testicular boost of radiation therapy Bone marrow is infused on day 0 Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1 3 6 and 11 Arm II T cell depletion is conducted by 2 different methods according to the institution and treatment varies depending on the method used Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion Method I Depending on the institution some patients receive TBI on days -9 to -7 before chemotherapy Course I and some receive TBI on days -3 to -1 after chemotherapy Course II Course I also includes cytarabine IV on days -5 to -3 cyclophosphamide IV on days -2 and -1 and methylprednisolone IV on days -2 to 0 and 5-18 Bone marrow infusion is administered on day 0 Cyclosporine begins on day -1 Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5 Methylprednisolone IV is administered on days -2 to 0 and 5-18 Bone marrow infusion is administered on day 0 Cyclosporine begins on day 0 Method II Preparative therapy varies according to the disease category Acute lymphoblastic leukemia Patients undergo TBI on days -7 to -4 Males receive testicular boost on day -7 and all receive electron boost to anterior and posterior chest wall on days -5 and -4 Cyclophosphamide IV is administered on days -3 and -2 Bone marrow infusion is administered on day 0 Acute nonlymphocytic leukemia chronic myelogenous leukemia and myelodysplastic syndrome Patients receive cyclophosphamide IV on days -7 and -6 followed by TBI on days -4 to -1 Bone marrow infusion is administered on day 0 Patients receive methylprednisolone IV every 12 hr on days -2-1 and 5-19 Cyclosporine is administered from day -3 to day 180 All patients on both arms receive filgrastim granulocyte colony-stimulating factor G-CSF beginning on day 7 post-transplant Patients are followed weekly for the first 14 weeks at day 100 every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 560 patients will be accrued for this study within 4 years
OUTLINE This is a randomized multicenter study Patients will be stratified according to institution Patients are assigned to one of two treatment arms one with conventional bone marrow transplantation arm I and one with T cell depletion of the bone marrow arm II Arm I Patients receive cyclophosphamide on days -6 and -5 Total body irradiation TBI is administered on days -4 to 0 although this order may be reversed Males with ALL receive a testicular boost of radiation therapy Bone marrow is infused on day 0 Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1 3 6 and 11 Arm II T cell depletion is conducted by 2 different methods according to the institution and treatment varies depending on the method used Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion Method I Depending on the institution some patients receive TBI on days -9 to -7 before chemotherapy Course I and some receive TBI on days -3 to -1 after chemotherapy Course II Course I also includes cytarabine IV on days -5 to -3 cyclophosphamide IV on days -2 and -1 and methylprednisolone IV on days -2 to 0 and 5-18 Bone marrow infusion is administered on day 0 Cyclosporine begins on day -1 Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5 Methylprednisolone IV is administered on days -2 to 0 and 5-18 Bone marrow infusion is administered on day 0 Cyclosporine begins on day 0 Method II Preparative therapy varies according to the disease category Acute lymphoblastic leukemia Patients undergo TBI on days -7 to -4 Males receive testicular boost on day -7 and all receive electron boost to anterior and posterior chest wall on days -5 and -4 Cyclophosphamide IV is administered on days -3 and -2 Bone marrow infusion is administered on day 0 Acute nonlymphocytic leukemia chronic myelogenous leukemia and myelodysplastic syndrome Patients receive cyclophosphamide IV on days -7 and -6 followed by TBI on days -4 to -1 Bone marrow infusion is administered on day 0 Patients receive methylprednisolone IV every 12 hr on days -2-1 and 5-19 Cyclosporine is administered from day -3 to day 180 All patients on both arms receive filgrastim granulocyte colony-stimulating factor G-CSF beginning on day 7 post-transplant Patients are followed weekly for the first 14 weeks at day 100 every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 560 patients will be accrued for this study within 4 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-G98-1388 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |
| MCV-CCHR-9504-2X | None | None | None |
| DUMC-75951 | None | None | None |