Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432419
Status:
TERMINATED
Last Update Posted:
2011-12-22
First Post:
2007-02-05
Brief Title:
Therapeutic Intensification of HIV-associated Non-Hodgkins Lymphoma by Peripheral Blood Cell Transplantation Following Chemotherapy
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Therapeutic Intensification for HIV-associated Non-Hodgkins Lymphoma by Autologous Transplantation of Either Unselected or CD34-Selected Peripheral Blood Stem Cells in Patients in First or Second Complete Remission ANRS 131
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
only one patient enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Given the poor prognosis of HIV-associated non-Hodgkins lymphoma NHL and its still high incidence in HAART era more intensive therapy is required in patients with initially severe stage of NHL or relapsing after first-line chemotherapy
The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by peripheral blood cell transplantation in these patients
The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by peripheral blood cell transplantation in these patients
Detailed Description:
Highly active antiretroviral therapy HAART has dramatically reduced mortality and morbidity of HIV-infected patients by decreasing the incidence of opportunistic infections and HIV-related malignancies such as Kaposi sarcoma However the frequency of NHL remains increased in these patients Moreover their prognostic remains poor comparing to HIV negative patients This is mainly due to the type of NHL aggressive B and frequent stage IV but also host factors such as immunodeficiency co-infections EBV HHV8 and chemotherapy-HAART interactions In the lack of new and significantly more efficient treatments therapeutic intensification such as high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation ASCT already tested in relapsed or partially responding HIV negative patients could be an option in HAART controlled HIV patients with NHL rather in first complete remission CR but with initially high International Prognosis Index IPI above or equal to 2 or in second CR whatever initial IPI Positive selection CD34 cells is an approach for depleting grafts of tumour cells and HIV DNA However the delayed lymphocyte recovery following this process may lead to increased incidence of opportunistic infections OI in HIV-infected patients OI prophylaxis will be systematically associated
Eligible patients will have peripheral blood stem cell PBSC mobilization and divided in two subgroups Group A with 3-6 x 106 PBSC will not undergo CD34 selection process and group B with more than 6 x 106 will undergo this process The myeloablative conditioning process is the same in the two groups with total body irradiation before reinfusion of grafts
Patients will be followed from week2 W2 up to W60 with clinical and biological evaluations
Eligible patients will have peripheral blood stem cell PBSC mobilization and divided in two subgroups Group A with 3-6 x 106 PBSC will not undergo CD34 selection process and group B with more than 6 x 106 will undergo this process The myeloablative conditioning process is the same in the two groups with total body irradiation before reinfusion of grafts
Patients will be followed from week2 W2 up to W60 with clinical and biological evaluations
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