RECRUITING

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Quick Facts

Study Start:2024-08-13
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06401356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Eligibility for Ongoing Pelabresib Treatment
  2. * Able to provide signed informed consent, agreeing to all protocol and ICF requirements.
  3. * At least 18 years old and legally able to consent in the study's jurisdiction.
  4. * Previously enrolled and currently receiving pelabresib in a parent study.
  5. * Demonstrating clinical benefit from pelabresib, as judged by the investigator.
  6. * Willing and able to follow all study visits, treatments, and procedures.
  7. * Agree to avoid pregnancy or fathering children:
  8. * Men: Must use highly effective contraception (≥99% effective) and avoid sperm donation from eligibility check through 94 days post-treatment.
  9. * 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.
  10. * Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible.
  11. 2. Eligibility for Survival Follow-up
  12. * Provide signed informed consent, agreeing to all protocol and ICF requirements.
  13. * Are at least 18 years old and legally able to consent.
  14. * Were previously enrolled in a pelabresib clinical study.
  15. * Are willing and able to comply with follow-up procedures.
  1. 1. Eligibility for Ongoing Pelabresib Treatment
  2. * Legally institutionalized or under judicial protection.
  3. * Enrolled in another interventional clinical trial (excluding the parent study).
  4. * History of hypersensitivity to pelabresib, its excipients, or similar drugs.
  5. * Significant gastrointestinal issues (e.g., active IBD, unresolved nausea/vomiting/diarrhea \> Grade 1) that may affect drug absorption.
  6. * Any medical condition deemed unsuitable by the investigator.
  7. * Uncontrolled illness or condition that may compromise safety or protocol compliance.
  8. * 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.)
  9. * Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.
  10. * Used strong CYP3A4 inhibitors/inducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited.
  11. * Female participants who are pregnant, breastfeeding, or not using required contraception.
  12. * Male participants who do not agree to use contraception or refrain from sperm donation as specified.
  13. * Unwilling or unable to comply with the study protocol.
  14. 2. Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)
Los Angeles, California, 90095-8344
United States
Mayo Clinic (Cancer Clinical Research Office)
Jacksonville, Florida, 32224-1865
United States
Northwestern Memorial Hospital (Oncology)
Chicago, Illinois, 60611-5957
United States
UMHS - University of Michigan Medical Center (Radiation Oncology)
Ann Arbor, Michigan, 48109-5000
United States
Mount Sinai Hospital - Oncology
New York, New York, 10029
United States
Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-08-13
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hematologic Malignancy
  • Solid Tumor
  • Advanced Malignancies