HIV InfectionsPhase 2NCT00127569
Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
A Phase 2 study testing Rituximab in people with HIV Infections and Giant Lymph Node Hyperplasia, run by French National Agency for Research on AIDS and Viral Hepatitis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Giant Lymph Node Hyperplasia
- What is being tested?
- Rituximab
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior treatment with rituximab
- Evolutive lymphoma or Kaposi's sarcoma needing treatment
- Absence of effective contraception
- Pregnancy
About this study
Official title: Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)
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.
Read the detailed description
HIV-related multicentric Castleman disease (MCD) is a lymphoproliferative disorder characterized by lymphadenopathy with angiofollicular hyperplasia and plasma cell infiltration, associated with KSHV/HHV-8. Patients typically have systemic manifestations such as fever associated with lymphadenopathy, hepatosplenomegaly, respiratory symptoms, peripheral edema, cytopenia, hypergammaglobulinemia, hypoalbuminemia, and high levels of serum C reactive protein (CRP). Symptoms correlate with an important increase of KSHV/HHV-8 DNA in peripheral blood mononuclear cells. HIV-MCD is characterized by a rapidly progressive and often fatal course. HIV-MCD is often refractory to treatment. Vinca alkaloids produce frequent but short-lived responses, and most patients remain dependant upon chemotherapy.
Lymph nodes of patients with HIV-MCD specifically harbor the virus in B cells located in the mantle zone, which stain positively for the CD20 surface antigen. Rituximab, a humanized monoclonal anti-CD20 antibody, has been reported to be effective in some cases, with conflicting data in other cases. The optimal schedule of infusions remains unclear.
Kaposi's sarcoma is often associated with HIV-MCD, and the development of aggressive non-Hodgkin's lymphoma is not a rare outcome.
- Conditions
- HIV Infections, Giant Lymph Node Hyperplasia
- Being tested
- Rituximab
- Keywords
- HIV infections, Giant Lymph Node Hyperplasia, Herpesvirus 8, Human, Rituximab (Mabthera), Antibodies, Monoclonal
- Medical subject headings
- HIV Infections, Castleman Disease, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
One-year overall survival
Change in HHV-8 viral load within one year
Change in lymphocyte B cell count within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startMay 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Investigators
- Eric Oksenhendler, M.D., Principal investigator, AP-HP Hopital Saint-Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127569
- Sponsor's protocol ID
- ANRS 117 CastlemaB
- Status last verified
- Jan 2007
- First submitted
- 4 Aug 2005
- Last updated
- 12 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)
- ClinicalTrials.gov ID
- NCT00127569
- Acronym / sponsor ID
- ANRS 117 CastlemaB
- Conditions
- HIV Infections, Giant Lymph Node Hyperplasia
- Keywords
- HIV infections, Giant Lymph Node Hyperplasia, Herpesvirus 8, Human, Rituximab (Mabthera), Antibodies, Monoclonal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2003
- Study completion
- Jan 2006
- First posted
- 8 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HIV-related multicentric Castleman disease (MCD) is a lymphoproliferative disorder characterized by lymphadenopathy with angiofollicular hyperplasia and plasma cell infiltration, associated with KSHV/HHV-8. Patients typically have systemic manifestations such as fever associated with lymphadenopathy, hepatosplenomegaly, respiratory symptoms, peripheral edema, cytopenia, hypergammaglobulinemia, hypoalbuminemia, and high levels of serum C reactive protein (CRP). Symptoms correlate with an important increase of KSHV/HHV-8 DNA in peripheral blood mononuclear cells. HIV-MCD is characterized by a rapidly progressive and often fatal course. HIV-MCD is often refractory to treatment. Vinca alkaloids produce frequent but short-lived responses, and most patients remain dependant upon chemotherapy.
Lymph nodes of patients with HIV-MCD specifically harbor the virus in B cells located in the mantle zone, which stain positively for the CD20 surface antigen. Rituximab, a humanized monoclonal anti-CD20 antibody, has been reported to be effective in some cases, with conflicting data in other cases. The optimal schedule of infusions remains unclear.
Kaposi's sarcoma is often associated with HIV-MCD, and the development of aggressive non-Hodgkin's lymphoma is not a rare outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prior treatment with rituximab
- Evolutive lymphoma or Kaposi's sarcoma needing treatment
- Absence of effective contraception
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab | Drug | – |
Primary outcome
Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab
8 secondary outcomes
One-year disease-free survival
One-year event-free survival
Relapse rate at day 365
One-year lymphoma-free survival
Tolerance of rituximab
One-year overall survival
Change in HHV-8 viral load within one year
Change in lymphocyte B cell count within one year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Oksenhendler, M.D. principal investigator
AP-HP Hopital Saint-Louis
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with HIV Infections and Giant Lymph Node Hyperplasia, run by French National Agency for Research on AIDS and Viral Hepatitis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained response rate of multicentric Castleman disease at day 60, after 4 infusions of rituximab. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2007.