Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005797
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2000-06-02
Brief Title:
Bone Marrow Transplant in Treating Patients With Hematologic Cancers
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 for Hematologic Malignancies A Treatment Approach Based on Risk of Relapse and Toxicity
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 drugs 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 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
PURPOSE This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers
PURPOSE This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers
Detailed Description:
OBJECTIVES
Determine the progression free survival PFS and overall survival OS of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation BMT
Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide total body irradiation and allogeneic BMT
Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients
Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia
OUTLINE
Regimen A Patients with chronic myelogenous leukemia CP1 APCP2 and other myeloproliferative disorders myelodysplastic disorders acute myelogenous leukemia CR1 or multiple myeloma not eligible to receive total body irradiation due to prior radiation are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation BMT Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Allogeneic bone marrow is infused on day 0
Regimen B Patients with acute myelogenous leukemia at least CR2 relapsed acute lymphoid leukemia ALL any acute leukemia with CNS involvement multiple myeloma or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT Patients receive total body irradiation TBI on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3 Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI Allogeneic bone marrow is infused on day 0
Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis
Patients are followed weekly for 3 months and then monthly for 1 year
PROJECTED ACCRUAL At least 50 patients with low risk myeloid disease 50 patients with lymphoid malignancies and 60 patients with high risk myeloid disease will be accrued for this study
Determine the progression free survival PFS and overall survival OS of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation BMT
Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide total body irradiation and allogeneic BMT
Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients
Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia
OUTLINE
Regimen A Patients with chronic myelogenous leukemia CP1 APCP2 and other myeloproliferative disorders myelodysplastic disorders acute myelogenous leukemia CR1 or multiple myeloma not eligible to receive total body irradiation due to prior radiation are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation BMT Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Allogeneic bone marrow is infused on day 0
Regimen B Patients with acute myelogenous leukemia at least CR2 relapsed acute lymphoid leukemia ALL any acute leukemia with CNS involvement multiple myeloma or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT Patients receive total body irradiation TBI on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3 Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI Allogeneic bone marrow is infused on day 0
Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis
Patients are followed weekly for 3 months and then monthly for 1 year
PROJECTED ACCRUAL At least 50 patients with low risk myeloid disease 50 patients with lymphoid malignancies and 60 patients with high risk myeloid disease will be accrued for this study
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-G00-1759 | OTHER_GRANT | NCI | None |
| MCC-IRB-4188 | OTHER | None | None |