HIV Infections Clinical Trial
Official title:
Therapeutic Intensification for HIV-associated Non-Hodgkin's Lymphoma by Autologous Transplantation of Either Unselected or CD34+-Selected Peripheral Blood Stem Cells, in Patients in First or Second Complete Remission. ANRS 131
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 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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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