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Therapeutic Intensification of HIV-associated Non-Hodgkin's Lymphoma by Peripheral Blood Cell Transplantation Following Chemotherapy.

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ClinicalTrials.gov Identifier: NCT00432419
Recruitment Status : Terminated (only one patient enrolled)
First Posted : February 7, 2007
Last Update Posted : December 22, 2011
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
HIV Infections Lymphoma, Non-Hodgkin Procedure: autologous peripheral blood cell transplantation Phase 1 Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety criteria defined as the occurrence of grades 3 or 4 adverse events in the 6 months following transplantation.

Secondary Outcome Measures :
  1. Evaluation of:
  2. HIV RNA
  3. HIV DNA
  4. Percentage and absolute count of CD3, CD4+ and CD8+ lymphocytes
  5. Lymphocyte phenotypes and functions
  6. TREC analysis
  7. Immune reconstitution in vivo
  8. Duration of aplasia

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432419


Locations
France
Servide d'Immunologie Clinique
Creteil, France, 94010
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Yves LEVY, MD, PhD Service d'Immunologie Clinique, Henri Mondor Hospital 94010 Creteil Cedex
Study Director: Genevieve CHENE, MD, PhD INSERM Unit 593, Bordeaux
More Information
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Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00432419     History of Changes
Other Study ID Numbers: ANRS131
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV
Non-Hodgkin's lymphoma
Peripheral blood stem cells transplantation

Additional relevant MeSH terms:
Lymphoma
HIV Infections
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes