Clinical trial · Interventional
Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)
NCT00127569CI-TRIAL-00000559terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Lymph Node Hyperplasia | — | UNRESOLVED | — |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab
Secondary outcomes (8)
- measure
- One-year disease-free survival
- measure
- One-year event-free survival
- measure
- Relapse rate at day 365
- measure
- One-year lymphoma-free survival
- measure
- Tolerance of rituximab
- measure
- One-year overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Prior treatment with rituximab * Evolutive lymphoma or Kaposi's sarcoma needing treatment * Absence of effective contraception * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.