Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002829
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Bone Marrow Transplantation in Treating Patients With Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-07
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 Radiation therapy uses high-energy x-rays to damage cancer cells and may be an effective treatment for lymphoma Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma
Detailed Description:
OBJECTIVES I Examine the potential role of high dose etoposide cyclophosphamide total body irradiation and bone marrow transplantation for patients at high risk for disease progression II Determine the value of monitoring the quality of remission by PCR assessment of BCl-2 III Evaluate the efficacy of alpha interferon for patients with evidence of residual or recurrent lymphoma IV Evaluate the efficacy of bone marrow purging by PCR assessment of BCl-2
OUTLINE Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state Etoposide is administered intravenously on day -8 Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6 Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment Total body irradiation is received on days -4 -3 -2 and -1 On day 0 allogeneic or autologous bone marrow is infused intravenously Patients with residual or recurrent lymphoma receive interferon alpha daily
PROJECTED ACCRUAL 35 allogeneic and 40 autologous patients are expected to be enrolled
OUTLINE Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state Etoposide is administered intravenously on day -8 Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6 Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment Total body irradiation is received on days -4 -3 -2 and -1 On day 0 allogeneic or autologous bone marrow is infused intravenously Patients with residual or recurrent lymphoma receive interferon alpha daily
PROJECTED ACCRUAL 35 allogeneic and 40 autologous patients are expected to be enrolled
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-94009 | OTHER | None | None |
| NCI-G96-0994 | None | None | None |
| CDR0000065027 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |