Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004145
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
1999-12-10
Brief Title:
Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2014-03
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Sometimes the transplanted cells are rejected by the bodys normal tissues Antithymocyte globulin may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the effect of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation on hematopoietic recovery in patients with hematologic malignancies II Determine the toxicities of this regimen in these patients III Determine the frequency of mixed hematopoietic chimerism in these patients after this therapy IV Determine the efficacy and toxicity of donor leukocyte infusions at relapse in these patients V Determine the response rates and survival of these patients after this therapy VI Determine the immune reconstitution of patients undergoing this therapy
OUTLINE Patients receive fludarabine IV over 30 minutes on days -9 to -5 cyclophosphamide IV over 1 hour on day -5 and antithymocyte globulin IV over 10 hours on days -5 to -2 Allogeneic peripheral blood stem cells are infused on day 0 Patients who achieve complete remission CR and then relapse or patients who achieve less than a CR before day 60 receive donor leukocyte infusions DLI over 30 minutes DLI are repeated as necessary for persistent disease Patients are followed at 1 3 and 6 months then at 1 and 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
OUTLINE Patients receive fludarabine IV over 30 minutes on days -9 to -5 cyclophosphamide IV over 1 hour on day -5 and antithymocyte globulin IV over 10 hours on days -5 to -2 Allogeneic peripheral blood stem cells are infused on day 0 Patients who achieve complete remission CR and then relapse or patients who achieve less than a CR before day 60 receive donor leukocyte infusions DLI over 30 minutes DLI are repeated as necessary for persistent disease Patients are followed at 1 3 and 6 months then at 1 and 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 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-G99-1618 | None | None | None |
| UCCRC-9581 | None | None | None |
| UCCRC-CTRC-9852 | None | None | None |