Phase 2 Lymphoma 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 with BPDCN (a rare blood and skin cancer) according to 2022 WHO diagnostic standards, and who have not yet received any treatment for it — including those with skin or lymph node involvement but no bone marrow involvement
• People aged 18 or older
• People who are able to understand the study and sign a consent form agreeing to take part
• People who are able to attend follow-up appointments as required by the trial
• People who have a reasonably good general health and activity level (ECOG score below 3 — confirm with trial site if unsure what this means)
• People whose kidneys are working well enough, based on a blood test result meeting a specific threshold
• People whose heart is functioning well enough, based on a heart scan showing the heart pumping at 50% or above, and no significant abnormalities on a heart tracing (ECG)
• People with an albumin (a blood protein) level at or above a certain threshold, indicating adequate nutritional status
• People whose liver is functioning within acceptable levels, based on specific blood test results
• People who are using a highly effective form of contraception (applies to men and women who could become pregnant)
• Women for whom a pregnancy test taken within one week before starting treatment comes back negative (where applicable)
• People who are covered by a social security system

Who may not be able to join:

• People who have taken part in another clinical trial involving an experimental drug within the 30 days before enrolling in this trial
• People who have previously been treated with venetoclax or tagraxofusp (the drugs being studied in this trial)
• People who have previously received chemotherapy or any other experimental treatment for BPDCN — except those who have taken hydroxyurea for fewer than 14 days at the time of joining
• People currently taking immune-suppressing medications, except for a low dose of prednisone (10 mg per day or less)
• People with a known allergy or sensitivity to tagraxofusp, venetoclax, or any of their ingredients
• People who are pregnant or breastfeeding
• People with a known active hepatitis B or C infection — though people with an undetectable viral load, or evidence of prior hepatitis B vaccination, may not be excluded (confirm with trial site)
• People with an active, uncontrolled infection (viral, bacterial, or fungal) that requires treatment
• People with significant heart conditions, such as certain types of heart failure, uncontrolled chest pain, a heart attack or stroke within the past 6 months, uncontrolled high blood pressure, or serious heart rhythm problems not controlled by medication
• People with significant conditions affecting the kidneys, lungs, nervous system, mental health, hormones, immune system, liver, or with bleeding disorders unrelated to their cancer
• People who have had another type of cancer within the past three years — though exceptions may apply for certain early-stage or fully treated cancers, such as early breast or cervical cancer, certain skin cancers, low-risk prostate cancer not requiring treatment, or a previous cancer that was fully removed or treated with the intent to cure
• People with a condition that prevents them from absorbing or taking oral medications (swallowed tablets or liquids)
• People with a hereditary condition called fructose intolerance

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