An extension study for patients previously enrolled in studies with pelabresib

Korábbi kezelés

• Had systemic anticancer treatment or treatment with investigational agents, with the exception of the study drug in the parent study or hormonal therapy, less than 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug (Section 7.10). NOTE: Hydroxyurea and anagrelide are permitted up to 24 hours prior to start of study drug.
• Had hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) or androgenic steroids less than 4 weeks before the first dose of study drug (Section 7.10)
• Had a strong CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose of study drug, including St. John’s wort (Section 7.10). Initiation of treatment or concomitant use of a strong CYP3A4 inhibitor or inducer during study treatment is prohibited.
• Had immunosuppressive agents with systemic activity (>10 mg QD prednisone or equivalent) less than 4 weeks before the first dose of study drug. Participants who received topical, nasal, intra-articular, inhaled, and other forms of corticosteroids without systemic activity are eligible (Section 7.10 ).
• Had a live vaccination within 30 days prior to the first dose of study drug, except for COVID-19 vaccination (Section 7.10)
• Concurrent enrollment in another interventional clinical trial (other than the parent study)
• participant with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the participant or compliance with the protocol
• Female participants who are pregnant or breastfeeding or not on adequate contraceptive therapy specified in inclusion criteria

Más betegség

• History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class
• Any other medical condition that, in the investigator’s opinion, makes the participant unsuitable for the study
• Participants with impaired gastrointestinal function or gastrointestinal disease, including active IBD, that could significantly alter the absorption of study drug, including any unresolved nausea, vomiting, or diarrhea > Grade 1

Egyéb

• Eligibility for Ongoing Pelabresib Treatment (criteria 1-14 ): 1. Participants who are legally institutionalized or under judicial protection
• Participants who are unwilling or unable to comply with this study protocol or study requirements
• A male participants who does not agree to use contraception as specified in the inclusion criteria during the treatment period and for at least 94 days after the last dose of pelabresib (if they have a heterosexual partner who is a WOCBP) and who does not refrain from donating sperm during this period
• Eligibility for Survival Follow-up : 1. participants who are legally institutionalized or under judicial protection

• Eligibility for Ongoing Pelabresib Treatment (criteria 1-6 ) 1. Capable of giving signed informed consent as described in Section 12.2.2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
• Eligibility for Survival Follow-up (4): Willingness and ability to comply with ongoing follow-up as indicated in this protocol
• Participant must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent
• Was previously enrolled and is still receiving treatment with pelabresib in a parent clinical study
• Is receiving clinical benefit from treatment with pelabresib in the parent study, as assessed by the investigator
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol
• Agrees to avoid pregnancy or fathering children based on the criteria below: a. Male participants and their female partners of childbearing potential must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from the time of the eligibility check through 94 days after the last dose of pelabresib. Additionally, male participants must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (Section 7.13.) should be communicated to the participants and their understanding confirmed. b. WOCBP must have a negative serum pregnancy test at the time of the eligibility check and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from the time of the eligibility check until the end of relevant systemic exposure (ie, through 184 days after the last dose of pelabresib). They must also agree to regular urine pregnancy testing through the study treatment period and monthly pregnancy testing up to 184 days after the last dose of pelabresib. They must also refrain from breastfeeding and donating oocytes during the course of study and for 184 days after the last dose of pelabresib. Permitted methods that are at least 99% effective in preventing pregnancy (Section 7.13) should be communicated to the participants and their understanding confirmed. c. Women without childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal with ≥12 months of amenorrhea without an alternative medical cause) are eligible. NOTE: Female participants who have been amenorrheic for at least 12 months resulting from chemo/radiotherapy are considered of childbearing potential and should agree to use adequate contraceptive measures (Section 7.13).
• Eligibility for Survival Follow-up (1): Capable of giving signed informed consent as described in Section 12.2.2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• Eligibility for Survival Follow-up (2) : Participant must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF
• Eligibility for Survival Follow-up (3): Participant was previously enrolled in a clinical study with pelabresib