NCT06401356 An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
| NCT ID | NCT06401356 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2024-08-13 with a primary completion date of 2027-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).
Eligibility Criteria
Inclusion Criteria: 1. Eligibility for Ongoing Pelabresib Treatment * Able to provide signed informed consent, agreeing to all protocol and ICF requirements. * At least 18 years old and legally able to consent in the study's jurisdiction. * Previously enrolled and currently receiving pelabresib in a parent study. * Demonstrating clinical benefit from pelabresib, as judged by the investigator. * Willing and able to follow all study visits, treatments, and procedures. * Agree to avoid pregnancy or fathering children: * Men: Must use highly effective contraception (≥99% effective) and avoid sperm donation from eligibility check through 94 days post-treatment. * Women of childbearing potential (WOCBP): Must test negative for pregnancy at eligibility, use highly effective contraception through 184 days post-treatment, undergo regular pregnancy testing, and avoid breastfeeding and oocyte donation during this period. * Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible. Note: Women with amenorrhea due to chemo/radiotherapy are considered WOCBP and must use contraception. 2. Eligibility for Survival Follow-up * Provide signed informed consent, agreeing to all protocol and ICF requirements. * Are at least 18 years old and legally able to consent. * Were previously enrolled in a pelabresib clinical study. * Are willing and able to comply with follow-up procedures. Exclusion Criteria: 1. Eligibility for Ongoing Pelabresib Treatment * Legally institutionalized or under judicial protection. * Enrolled in another interventional clinical trial (excluding the parent study). * History of hypersensitivity to pelabresib, its excipients, or similar drugs. * Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption. * Any medical condition deemed unsuitable by the investigator. * Uncontrolled illness or condition that may compromise safety or protocol compliance. * Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose. (Hydroxyurea/anagrelide allowed up to 24 hours prior.) * Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose. * Used strong CYP3A4 inhibitors/inducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited. * Female participants who are pregnant, breastfeeding, or not using required contraception. * Male participants who do not agree to use contraception or refrain from sperm donation as specified. * Unwilling or unable to comply with the study protocol. 2. Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06401356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06401356 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT06401356 currently recruiting?
Yes, NCT06401356 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06401356 trial being conducted?
This trial is being conducted at Los Angeles, United States, Jacksonville, United States, Chicago, United States, Ann Arbor, United States and 11 additional locations.
Who is sponsoring the NCT06401356 clinical trial?
NCT06401356 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 50 participants.