Status:
TERMINATED
Therapeutic Intensification of HIV-associated Non-Hodgkin's Lymphoma by Peripheral Blood Cell Transplantation Following Chemotherapy.
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high incidence in HAART era, more intensive therapy is required in patients with initially severe stage of NHL or...
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 malignanc...
Eligibility Criteria
Inclusion
- Adult patients between 18 and 55 years old at screening
- Documented HIV-1 infection
- Currently HAART-treated
- Plasma HIV-RNA below 50 copies/ml at screening
- Lymphocyte T CD4+ count above or equal to 100/mm3 at the NHL diagnosis
- Histologically proven large cell NHL in first remission with classical poor prognostic factors (IPI above or equal to 2) or in second remission whatever IPI.
- Biological criteria of eligibility for intensive therapeutic
- Signed written informed consent
- Patient protected by the social security of one of the European community countries.
Exclusion
- Burkitt NHL
- Central nervous system NHL
- Patients already treated by ASCT
- Ongoing infectious disease
- Psychiatric disease
- Left ventricular ejection fraction \< 25%
- Creatinine clearance \< 50 ml/min
- Hepatic failure
- Uncontrolled high blood pressure
- Chronic hepatitis C or B
- Participating in other trials.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00432419
Start Date
February 1 2007
End Date
October 1 2008
Last Update
December 22 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Servide d'Immunologie Clinique
Créteil, France, 94010