Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005804
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2000-06-02
Brief Title:
Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Treatment of Patients With Hematological Malignancies Using Marrow Transplantation From Unrelated Donors Incompatible for One HLA Locus Antigen
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 Radiation therapy uses high-energy x-rays to damage cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Compare the incidence of graft-versus-host disease GVHD grades III and IV in patients with hematologic malignancies treated with bone marrow transplantation BMT using donors with 1 HLA-A or B non-cross-reactive group mismatch vs control patients previously treated with BMT using donors with 1 HLA-A or B cross-reactive group CREG mismatch
Compare the incidence of GVHD grades III and IV in patients with hematologic malignancies treated with BMT using donors with 1 HLA-A or B CREG mismatch vs control patients previously treated with BMT using matched donors
Determine the relevance of HLA-DRB1 or DQB1 allele mismatching in BMT using donors matched for HLA-A B and C
OUTLINE Beginning at least 3 weeks after completion of cytoreductive combination chemotherapy patients under age 18 undergo total body irradiation TBI twice a day on days -7 to -4 Patients age 18 and over undergo TBI twice a day on days -6 to -4 All patients then receive cyclophosphamide IV daily on days -3 and -2 Males with acute lymphocytic leukemia high-grade lymphoma intermediate-grade lymphoma or marrow or CNS involvement receive radiotherapy boost to the testes On day 0 patients receive infusion of bone marrow from unrelated donors with 1 of the following 1 HLA-A or B non-cross-reactive group mismatch 1 HLA-A or B cross-reactive group mismatch or an HLA-A B and C match with an HLA-DRB1 or DQB1 mismatch
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 5 years
Compare the incidence of graft-versus-host disease GVHD grades III and IV in patients with hematologic malignancies treated with bone marrow transplantation BMT using donors with 1 HLA-A or B non-cross-reactive group mismatch vs control patients previously treated with BMT using donors with 1 HLA-A or B cross-reactive group CREG mismatch
Compare the incidence of GVHD grades III and IV in patients with hematologic malignancies treated with BMT using donors with 1 HLA-A or B CREG mismatch vs control patients previously treated with BMT using matched donors
Determine the relevance of HLA-DRB1 or DQB1 allele mismatching in BMT using donors matched for HLA-A B and C
OUTLINE Beginning at least 3 weeks after completion of cytoreductive combination chemotherapy patients under age 18 undergo total body irradiation TBI twice a day on days -7 to -4 Patients age 18 and over undergo TBI twice a day on days -6 to -4 All patients then receive cyclophosphamide IV daily on days -3 and -2 Males with acute lymphocytic leukemia high-grade lymphoma intermediate-grade lymphoma or marrow or CNS involvement receive radiotherapy boost to the testes On day 0 patients receive infusion of bone marrow from unrelated donors with 1 of the following 1 HLA-A or B non-cross-reactive group mismatch 1 HLA-A or B cross-reactive group mismatch or an HLA-A B and C match with an HLA-DRB1 or DQB1 mismatch
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| CDR0000067780 | REGISTRY | PDQ | None |
| FHCRC-146700 | None | None | None |
| NCI-H00-0054 | None | None | None |