Phase 2 Castleman Disease Trial, Active, Not Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been newly diagnosed or previously treated for a condition called KSHV-associated Multicentric Castleman Disease (MCD), confirmed by a tissue biopsy showing specific features under a microscope.
• You are 18 years old or older at the time of signing the consent form.
• You are able to give your informed consent to participate.
• You may be HIV-positive or HIV-negative.
• If you are HIV-positive, you must already be on — or willing to start — HIV treatment that includes either lamivudine or tenofovir.
• You are willing and able to attend all required study visits.
• You are currently experiencing an active MCD flare, meaning you have a fever (felt or measured), swollen lymph nodes or an enlarged liver or spleen, AND at least one of the following: losing more than 5% of your body weight, feeling generally unwell, low red blood cell levels (anaemia) in the past 4 weeks, or low platelet counts. (If only two of these three groups of symptoms are present but your doctor still feels treatment is needed, participation may still be allowed after discussion with the lead study doctor.)
• If you received a blood transfusion recently due to low haemoglobin, you may still be eligible — your haemoglobin level before the transfusion will be considered.
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 3 days before joining the trial.
• If you are a woman who could become pregnant, you must agree not to breastfeed during treatment and for 6 months after treatment ends.
• If you are a woman who could become pregnant, you must agree to either avoid sexual intercourse with a male partner or use two reliable forms of contraception from the time of consent until 12 months after treatment ends.
• If you are a man with a female partner, you must either have had a vasectomy or agree to use effective contraception (such as a condom plus spermicide) from your first dose of treatment until 6 months after your last dose.
• You must not have used steroid medications (such as prednisone) for more than 7 days immediately before starting the study treatment. If you have, you will need a 7-day break from steroids before you can enrol.

Who may not be able to join:

• You have a severe and advanced form of a skin/organ condition called Kaposi Sarcoma (KS) that needs urgent treatment, as one of the study drugs could potentially make KS worse.
• You have previously been treated with a drug called rituximab specifically for MCD.
• You have another active cancer that currently requires treatment with systemic (whole-body) therapy.
• You are HIV-negative and have an active or chronic Hepatitis B infection, unless you are already taking tenofovir or lamivudine (confirm with trial site if unsure about your Hepatitis B status).
• You currently have an active infection that requires treatment with systemic (whole-body) medicines such as antibiotics or antifungals.
• You have taken part in another clinical drug trial and received an experimental medication within the past 28 days.
• You have been taking steroid medications continuously for more than 7 days right before enrolling and have not yet had a 7-day break from them.
• Your liver function test result called bilirubin is above a certain level (3 mg/dL) (confirm with trial site).
• Your kidneys are not working well enough, based on a specific calculation of kidney function (confirm with trial site).
• Your overall health and ability to carry out daily activities is severely limited, based on a standard medical scale called the ECOG performance status (confirm with trial site).
• You are currently pregnant or breastfeeding. Please note that breast milk cannot be stored for later use while you are being treated in this study.

Important: Always verify eligibility with the trial site directly before applying.