Continued treatment with pelabresib for patients from previous studies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study provides ongoing access to pelabresib for patients who have previously participated in studies involving this treatment. It aims to gather additional safety and efficacy data while monitoring overall survival and leukemia-free survival rates. Patients who received pelabresib or placebo in earlier studies will be followed up to assess their health outcomes. The study will also collect information on adverse events related to the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California LA
  Los Angeles, California, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Uni Of Michigan Health System
  Ann Arbor, Michigan, United States Recruiting
• New York Presbyterian Hospital
  New York, New York, United States Recruiting
• Mt Sinai Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QH101 Vδ2 T-cell therapy for adults with relapsed or advanced malignant tumors

  This study will try QH101, an off-the-shelf Vδ2 T-cell therapy, in adults with relapsed or advanced blood cancers or solid tumors to see if it is safe and helps fight tumors.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07570563

• Pharmacist-led program to help patients take oral cancer medicines as prescribed

  This program will test whether pharmacist counseling and risk-based monitoring helps adults with solid tumors or blood cancers who have been on oral cancer medicines for at least six months take their medication more consistently.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06989489

• A tool to improve family communication in pediatric stem cell transplant decisions

  This study is testing a new tool to help families talk better and make decisions together about stem cell transplants for kids aged 8 to 17.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT06689800

• Evaluating the delayed effects of CAR T cell therapy in children

  This study looks at the short-term and long-term side effects of CAR T cell therapy in children with certain types of cancer to see how it affects them over time.

  Recruiting at 7 sites St. Jude Children's Research Hospital · Los Angeles, California and 6 other locations · NCT06579469

• High-dose vs standard-dose flu vaccine in adults with blood cancers on B-cell-depleting therapy

  This study tests whether a high-dose flu shot evokes a stronger immune response than a standard-dose shot in adults with hematologic cancers who recently had B-cell-depleting therapy.

  Recruiting Phase 2 Asan Medical Center · Seoul · NCT07926217

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.