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
18 Years
55 Years
Both
HIV Infections, Lymphoma, Non-Hodgkin
Trial Information
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
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety criteria defined as the occurrence of grades 3 or 4 adverse events in the 6 months following transplantation.
Principal Investigator
Yves LEVY, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Service d'Immunologie Clinique, Henri Mondor Hospital 94010 Creteil Cedex
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ANRS131
NCT ID:
NCT00432419
Start Date:
February 2007
Completion Date:
October 2008
Related Keywords:
- HIV Infections
- Lymphoma, Non-Hodgkin
- HIV
- Non-Hodgkin's lymphoma
- Peripheral blood stem cells transplantation
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Lymphoma
- Lymphoma, Non-Hodgkin
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