Phase 2 Castleman Disease Trial, 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:

• People who have been diagnosed (confirmed by tissue testing) with primary effusion lymphoma (PEL), plasmablastic lymphoma (PBL), or a related condition called KSHV-associated multicentric Castleman disease (MCD), where the disease has come back or stopped responding to treatment, or where first-line chemotherapy is not suitable for them.
• People aged 18 or older.
• People of any HIV status.
• People living with HIV must be on, or about to start, an effective HIV treatment plan, and their HIV levels in the blood must be very low (below 200 copies/mL).
• People with PEL or PBL must have lymphoma that can be measured or detected on scans or tests.
• People with PEL or PBL must have a general health status rated 0–2 on a standard scale, or rated 3 if that decline is caused by PEL or PBL itself (confirm with trial site).
• People with PEL or PBL must have blood counts and kidney function within acceptable ranges: a haemoglobin level above 7 g/dL, and kidney filtration rate of at least 15 mL/min/1.73 m².
• People with PEL or PBL must have already received first-line chemotherapy containing a drug type called an anthracycline, unless that type of chemotherapy is not medically safe for them.
• People with KSHV-MCD must have a general health status rated 0–2, or rated 3 if caused by MCD itself.
• People with KSHV-MCD must have blood counts and kidney function in acceptable ranges: haemoglobin above 7 g/dL and kidney filtration rate of at least 15 mL/min/1.73 m².
• People with KSHV-MCD must have at least one symptom linked to MCD, such as fever above 38°C, tiredness, stomach or digestive problems, breathing or sinus problems, or a rash.
• People with KSHV-MCD must also have at least one abnormal blood test result linked to MCD, such as low red blood cell levels, low platelet count, low protein (albumin), low sodium, or raised inflammation markers.
• People with a chronic hepatitis B infection must be on treatment that keeps the virus at undetectable levels.
• People who have had hepatitis C must have completed antiviral treatment with no detectable virus for at least 12 weeks.
• People who have taken an experimental drug in another trial must have waited at least 2 weeks, or 5 times the drug's clearance time from the body (whichever is longer), before joining.
• Women who could become pregnant must agree to use effective contraception before joining and for 3 months after the last dose, and must not donate eggs during that time.
• Men must agree to use effective contraception during the study and for 3 months after the last dose.
• People who are breastfeeding must be willing to stop from the start of treatment through to 3 months after the last dose.
• Participants must be able to understand and sign a written consent form.

Who may not be able to join:

• People who have received cancer treatment in the last 2 weeks, unless that treatment is for a separate, low-risk cancer (such as local treatment for very early-stage cancer or hormone therapy for prostate or breast cancer) that is unlikely to affect the trial — side effects from past treatments (other than hair loss or nerve-related symptoms) must have settled down to a mild level.
• People who have Kaposi sarcoma (KS) that urgently needs chemotherapy treatment.
• People with significantly elevated liver-related blood test results (total bilirubin more than 1.5 times the normal upper limit, or liver enzymes AST/ALT more than 3 times the normal upper limit), unless the elevation is due to a specific inherited condition called Gilbert's syndrome, or is caused by HIV medication or the lymphoma itself (confirm with trial site).
• People with low white blood cell counts (below 1,000/mm³) or low platelet counts (below 75,000/mm³), unless those low levels are caused by the lymphoma, MCD, or previous treatment.
• People with life-threatening or organ-threatening complications of KSHV-MCD.
• People with significant heart problems, including a heart attack within the past 6 months, unstable or poorly controlled heart disease, severe heart failure, or an uncontrolled irregular heartbeat.
• People with severe chronic lung disease (COPD) where lung function tests show capacity below 50% of what is expected.
• People with moderate to severe persistent asthma in the past 2 years, or asthma that is not well controlled — people with mild or well-controlled asthma may still be considered.
• People who are pregnant, confirmed by a positive pregnancy blood or urine test.
• People with serious, uncontrolled illness unrelated to their lymphoma — people whose severe illness is caused by the lymphoma itself may still be considered at the trial doctor's discretion.

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