NCT00127569

Brief Summary

This trial is aimed to study the efficacy of 4 weekly cycles of rituximab in HIV-infected patients with multicentric Castleman disease (giant lymph node hyperplasia) dependent on chemotherapy. Efficacy is assessed by the complete response rate at day 60. The patients are followed until day 365.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started May 2003

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 12, 2007

Status Verified

January 1, 2007

First QC Date

August 4, 2005

Last Update Submit

January 11, 2007

Conditions

HIV InfectionsGiant Lymph Node Hyperplasia

Keywords

HIV infectionsGiant Lymph Node HyperplasiaHerpesvirus 8, HumanRituximab (Mabthera)Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (1)

  • Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab

Secondary Outcomes (8)

  • One-year disease-free survival

  • One-year event-free survival

  • Relapse rate at day 365

  • One-year lymphoma-free survival

  • Tolerance of rituximab

  • +3 more secondary outcomes

Interventions

RituximabDRUG

Eligibility Criteria

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

You may qualify if:

  • Confirmed multicentric Castleman disease, with dependence on vinblastine or VP16 for at least 3 months, whenever they have been splenectomized
  • At least one Castleman crisis since onset of chemotherapy
  • Ongoing highly active antiretroviral therapy (HAART) for at least 3 months
  • No threshold of CD4 cell count and HIV-RNA
  • Signed written informed consent

You may not qualify if:

  • Prior treatment with rituximab
  • Evolutive lymphoma or Kaposi's sarcoma needing treatment
  • Absence of effective contraception
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsCastleman DiseaseSarcoma, Kaposi

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersHerpesviridae InfectionsDNA Virus InfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eric Oksenhendler, M.D.

    AP-HP Hopital Saint-Louis

    PRINCIPAL INVESTIGATOR

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 4, 2005

First Posted

August 8, 2005

Study Start

May 1, 2003

Study Completion

January 1, 2006

Last Updated

January 12, 2007

Record last verified: 2007-01