NCT00126243

Brief Summary

Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for patients with low response rates, high number of relapses and AIDS events. The addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
Last Updated

August 17, 2005

Status Verified

August 1, 2005

First QC Date

August 2, 2005

Last Update Submit

August 16, 2005

Conditions

AIDS Related Lymphoma

Keywords

AIDS related Lymphomachemotherapyrituximab

Outcome Measures

Primary Outcomes (1)

  • Evaluate the response rate of lymphoma treated

Secondary Outcomes (4)

  • Duration of response

  • Evaluate the time to progression

  • Survival

  • Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy

Interventions

rituximabDRUG
CHOPDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin's lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: \*Burkitt's lymphoma, \*diffuse large B-cell with standard histological diagnosis, \*Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive
  • Good and intermediate prognostic group (no more than one of the following prognostic factors: \*CD4 below 100/µl, \*history of opportunistic infection, \*Karnofsky index below 60 percent or ECOG over 2)
  • Written inform consent to participate

You may not qualify if:

  • Active viral hepatitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Medecine Interne Hopital Antoine Beclere

Clamart, 92140, France

Location

MeSH Terms

Conditions

Lymphoma, AIDS-Related

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Francois Boue, MD

    Service de Medecine Interne Hopital A Beclere Clamart France

    PRINCIPAL INVESTIGATOR

  • Dominique Costagliola

    Inserm U 720

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

January 1, 1999

Study Completion

October 1, 2003

Last Updated

August 17, 2005

Record last verified: 2005-08

Locations

FR(1)