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

This study has been terminated.
(only one patient enrolled)
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00432419
First received: February 5, 2007
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
HIV Infections
Lymphoma, Non-Hodgkin
Procedure: autologous peripheral blood cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Secondary Outcome Measures:
  • Evaluation of:
  • HIV RNA
  • HIV DNA
  • Percentage and absolute count of CD3, CD4+ and CD8+ lymphocytes
  • Lymphocyte phenotypes and functions
  • TREC analysis
  • Immune reconstitution in vivo
  • Duration of aplasia

Enrollment: 1
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00432419     History of Changes
Other Study ID Numbers: ANRS131
Study First Received: February 5, 2007
Last Updated: December 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lymphoma
Lymphoma, Non-Hodgkin
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on July 20, 2014