Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003942
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Gene Therapy Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkins Lymphoma
Sponsor:
Systemix
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of the Safety and Feasibility of REVM10 or REVM10ANTISENSE POL 1 Transduced Hematopoietic Stem Cells HSC in HIV-1 Related Non-Hodgkins Lymphoma Patients Already Being Treated With High Dose Chemotherapy and Peripheral Blood Stem Cell Support
Status:
UNKNOWN
Status Verified Date:
2000-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Inserting the gene for RevM10 into a persons peripheral stem cells may improve the bodys ability to fight cancer or make the cancer more sensitive to chemotherapy
PURPOSE Phase III trial to study the effectiveness of RevM10-treated stem cells plus chemotherapy and peripheral stem cell transplantation in treating patients who have HIV-related non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of RevM10-treated stem cells plus chemotherapy and peripheral stem cell transplantation in treating patients who have HIV-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the safety of infusion of RevM10 or RevM10polAS transduced hematopoietic stem cells HSC in addition to high dose chemotherapy and standard peripheral blood stem cell support in patients with HIV-1 related non-Hodgkins lymphoma II Determine gene marking of lymphocytes and myeloid cells in peripheral blood bone marrow andor lymph nodes after infusion of RevM10-HSC or RevM10polAS-HSC in these patients III Determine the antiretroviral effect of this treatment in these patients
OUTLINE This is a multicenter study Patients receive mobilization therapy and undergo leukapheresis according to a standard protocol High dose chemotherapy is administered on days -7 to -1 also according to a standard protocol On day 0 autologous hematopoietic stem cells transduced with genes RevM10 or RevM10polAS are infused Unmodified autologous peripheral blood stem cells are reinfused on day 1 Patients are followed daily for 2 weeks weekly for 2 weeks monthly for 1 year then annually thereafter
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study within 14 months
OUTLINE This is a multicenter study Patients receive mobilization therapy and undergo leukapheresis according to a standard protocol High dose chemotherapy is administered on days -7 to -1 also according to a standard protocol On day 0 autologous hematopoietic stem cells transduced with genes RevM10 or RevM10polAS are infused Unmodified autologous peripheral blood stem cells are reinfused on day 1 Patients are followed daily for 2 weeks weekly for 2 weeks monthly for 1 year then annually thereafter
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study within 14 months
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-G99-1549 | None | None | None |
| SYSTEMIX-105 | None | None | None |
| UCLA-HSPC-980303601D | None | None | None |