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

NCT00432419 | Terminated Phase 1 DMC

• 1 other identifier: ANRS131
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Lymphoma, Non-Hodgkin

Keywords

HIV; Non-Hodgkin's lymphoma; Peripheral blood stem cells transplantation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• Evaluation of:

• HIV RNA

• HIV DNA

• Percentage and absolute count of CD3, CD4+ and CD8+ lymphocytes

• Lymphocyte phenotypes and functions

Interventions

autologous peripheral blood cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Servide d'Immunologie Clinique

Créteil, 94010, France

Location

MeSH Terms

Conditions

HIV Infections; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Yves LEVY, MD, PhD

  Service d'Immunologie Clinique, Henri Mondor Hospital 94010 Creteil Cedex

  PRINCIPAL INVESTIGATOR

• Genevieve CHENE, MD, PhD

  INSERM Unit 593, Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 7, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

FR (1)