Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 formally diagnosed with classical hairy cell leukemia (a specific type of blood cancer), confirmed by laboratory testing, and whose cancer has a specific gene change called BRAF V600E
• People in Phase 1 of the trial who have already received at least one prior treatment containing a type of chemotherapy drug called a purine nucleoside analog (such as fludarabine, pentostatin, or cladribine), unless that type of treatment was not medically appropriate for them
• People in Phase 2 of the trial (front-line group) who have never previously received any treatment for their hairy cell leukemia
• Adults aged 18 or older
• People whose hairy cell leukemia is causing at least one of the following: very low white blood cell counts, low platelet counts, low red blood cell counts (anaemia), recurring infections, swollen lymph nodes or bone lesions, an enlarged spleen or liver, or disease-related symptoms such as significant unexplained weight loss, severe tiredness, fever, or night sweats lasting more than two weeks without infection
• People who are well enough to carry out basic daily activities, as measured by a standard medical scale (confirm with trial site), or whose reduced functioning is considered to be caused by the leukemia itself
• People with liver function blood test results within acceptable ranges as determined by the trial site
• People whose kidneys are filtering at an adequate level (confirm with trial site)
• People living with HIV who are on effective treatment and have had no detectable virus in their blood within the past 6 months
• People with a history of hepatitis B who have undetectable virus levels while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with no detectable virus for more than 6 months
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's assessments
• People whose heart electrical activity (measured by an ECG) does not show significant rhythm problems or reduced blood supply, and whose heart's QT interval measurement is within an acceptable range
• People who are able to understand the trial and are willing to sign a consent form (a legal representative may sign on their behalf)
• People who agree to use two forms of contraception — including one highly effective method plus a barrier method — during treatment and for 12 months after the last dose; women of childbearing potential should use effective non-hormonal contraception during this period, and male participants should use a condom in addition to another highly effective method

Who may not be able to join:

• People whose hairy cell leukemia has spread to the brain or central nervous system (though people with previously treated brain involvement and no sign of disease progression on follow-up scans may still be considered)
• People whose hairy cell leukemia does not have the BRAF V600E gene change, or who have a related but different condition called variant hairy cell leukemia
• People with a platelet count below 50,000 per microlitre of blood
• People currently taking the blood-thinning medications warfarin or direct oral anticoagulants, due to bleeding risk
• People who still have significant side effects (above a mild level) from a previous cancer treatment, except for hair loss
• People currently taking part in another clinical trial involving an experimental treatment
• People currently taking certain medications that strongly affect how the body processes a specific enzyme (CYP2C8), or certain other interacting drug types (confirm with trial site)
• People who are pregnant, breastfeeding, or unwilling to use adequate contraception throughout the trial and for 12 months after the final dose
• People who have previously had a serious allergic reaction to medications similar in composition to the drugs used in this trial, including people who have had a severe infusion reaction (such as anaphylaxis) to rituximab
• People with a known allergy or sensitivity to any of the study drugs
• People who are unable to swallow tablets or capsules, or who have conditions affecting the digestive system that would prevent proper absorption of the medication
• People who have received a live or live-attenuated vaccine within 28 days before joining the trial
• People with serious uncontrolled illness or other significant health conditions that would make participation unsafe
• People who are pregnant or breastfeeding, given the potential harm the study drugs may cause to an unborn baby or nursing infant

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