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An Extension Study for Patients Previously Treated with Pelabresib

This study is for patients who have previously received pelabresib in another clinical trial. It aims to understand the long-term safety and benefits of pelabresib, a small molecule inhibitor (a type of drug that blocks specific processes in cells) for certain cancers. You might be eligible if you have a blood cancer (hematologic malignancy), a solid tumor, or other advanced cancers and are currently receiving pelabresib, or if you previously received pelabresib or a placebo in a prior study. Researchers will track side effects, how long the treatment works, and survival for up to five years. The study plans to enroll 50 participants.

Study design
This is an interventional study for patients previously treated with pelabresib, with a planned enrollment of 50 participants.
What's involved
You would continue receiving pelabresib as long as it's tolerated. The study involves regular visits to monitor your health, disease status, and any side effects.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and survival for up to five years after their last dose of pelabresib.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06401356

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~50 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Pelabresib

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-emergent adverse events (TEAEs) and serious TEAEs
Measured over 5 years
+4 more outcomes measured

Conditions

Hematologic Malignancy
Solid Tumor
Advanced Malignancies

Explore related trials

Malignant neoplasm of lymphoid, hematopoietic and/or related tissueSolid Neoplasm

NCT06401356

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic Jacksonville

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Mt Sinai Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • New York Presbyterian Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Northwestern University

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Uni Of Michigan Health System

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • University of California LA

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Novartis Investigative Site

    Antwerp, Belgiumno site contact published

    Recruiting

  • Novartis Investigative Site

    Bruges, Belgiumno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Treatment-emergent adverse events (TEAEs) and serious TEAEs5 years

    To evaluate long-term safety in patients who are receiving pelabresib

  • Survival Follow-up5 years

    Survival Follow-up consists of Survival and Leukemia-Free Survival Follow-up. All participants in the extension study will be followed up for Survival, while participants with hematological malignancies will be followed up for Survival and Leukemia-Free Survival. In addition, participants who will not receive pelabresib treatment may enter this extension protocol to be only followed up for Survival.

  • Duration of Response (DoR)5 years

    DOR defined as the time from the date of first response to the date of confirmed disease progression

  • Progression-free survival (PFS)5 years

    PFS defined as the time from first dose to confirmed disease progression or death, whichever occurs first.

  • Leukemia-free survival (LFS)5 years

    LFS defined as the time from first dose to the date of leukemic transformation or death, whichever occurs first.