Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002553
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN
Status:
COMPLETED
Status Verified Date:
2011-11
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine whether the use of donors with a one non crossreactive group CREG mismatch for HLA-A or B in patients less than 36 years of age is associated with more frequent graft versus host disease GVHD of grades III-IV than previously observed with donors with one CREG mismatch II Determine whether the use of donors with a one CREG mismatch for HLA-A or B in patients 36-50 years of age is associated with more frequent GVHD of grades III-IV than previously observed with matched donors III Determine the relevance of HLA-A allele mismatching in bone marrow transplants from donors matched for HLA-A B and DR phenotypes
OUTLINE This is a parallel open label study Patients are assigned to 1 of 3 treatment arms Arm I Patients receive cyclophosphamide IV on days -7 and -6 and total body irradiation TBI 3 times a day on days -4 through -1 Allogeneic bone marrow ABM is infused on day 0 Arm II Patients receive therapy as in arm I except TBI is administered twice a day on day -1 only ABM is infused on day 0 Arm III Patients receive cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1 ABM is infused on day 0 Males with ALL receive an additional radiation boost to the testes during TBI Patients are followed at least every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 50 patients under 36 years old and 50 patients 36-50 years old will be accrued for this study within 5 years Additional patients will be accrued for the standard therapy arm of this study
OUTLINE This is a parallel open label study Patients are assigned to 1 of 3 treatment arms Arm I Patients receive cyclophosphamide IV on days -7 and -6 and total body irradiation TBI 3 times a day on days -4 through -1 Allogeneic bone marrow ABM is infused on day 0 Arm II Patients receive therapy as in arm I except TBI is administered twice a day on day -1 only ABM is infused on day 0 Arm III Patients receive cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1 ABM is infused on day 0 Males with ALL receive an additional radiation boost to the testes during TBI Patients are followed at least every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 50 patients under 36 years old and 50 patients 36-50 years old will be accrued for this study within 5 years Additional patients will be accrued for the standard therapy arm of 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-H94-0372 | None | None | None |
| CDR0000063397 | None | None | None |