An Extension Study for Patients Previously Enrolled in Studies with Pelabresib

Last Update: Dec 17, 2024
An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies with Pelabresib
ClinicalTrials.gov Identifier:
Novartis Reference Number:CNST0610C210
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is:

1. To provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information
2. To evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies The purpose of this study is to provide continued access to pelabresib treatment for patients who previously received pelabresib in a parent study and to continue collecting information on safety and efficacy.

By collecting efficacy and safety information, the study team will monitor the efficacy of pelabresib with regard to disease status and survival, as well as information on AEs, including SAEs and AEs of special interest (AESIs),

Additionally, survival follow-up data will be collected from patients who continued treatment with pelabresib in this extension study, and may also be collected from patients who discontinued treatment with placebo or pelabresib in pelabresib parent studies.

During the survival follow-up, the team will collect information on the leukaemia-free survival status and overall survival (lifespan) of the patient during and after the end of treatment.

If a patient discontinued pelabresib treatment in the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment in this extension study, but they can enter the study for survival-follow up only.

Hematologic Malignancy, Solid Tumor, Advanced Malignancies
Phase3
Recruiting
50
Aug 13, 2024
Jun 30, 2029
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Pelabresib

Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Eligibility Criteria

Inclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Capable of giving signed informed consent
2. Receiving clinical benefit from treatment with pelabresib in the parent study
3. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Capable of giving signed informed consent Patient 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
2. Patient has been enrolled in a clinical study with pelabresib
3. Willingness and ability to comply with ongoing follow-up as indicated in this protocol

Exclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Patients who are legally institutionalized or under judicial protection
2. Any medical condition that, in the investigator's opinion, makes the patient unsuitable for the study
3. Patient is able to access pelabresib outside the study
4. Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
5. Female patients who are pregnant or breastfeeding

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Patients who are legally institutionalized or under judicial protection

Az St-Jan Brugge-Oostende A.V.

Recruiting

Brugge,8000,Belgium

Jan Van Droogenbroeck

ZNA Cadix-Hematology

Recruiting

Antwerpen,2020,Belgium

Nikki Granacher

AOU Careggi (Department of Experimental and Clinical Medicine)

Recruiting

Firenze,50141,Italy

Alessandro Vannucchi

AO Ospedale di Circolo, PO Varese (Ematologia)

Recruiting

Varese,21100,Italy

Marco Brociner

Amsterdam UMC location Vumc (Hematology)

Recruiting

Amsterdam,1081 hv,Netherlands

Marielle Wondergem

Guys and St Thomas' Hospital - Haematology

Recruiting

London,Se1 9rt,United Kingdom

Claire Harrison

Cardiff and Vale University Health Board - University Hospital Wales (Hematology)

Recruiting

Cardiff,Cf14 4xw,United Kingdom

Steven Knapper

Beatson West of Scotland Cancer Centre (Hematology)

Recruiting

Glasgow,G12 0yn,United Kingdom

Mark Drummond

Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)

Recruiting

Los Angeles,California,90095-8344,United States

Gary J Schiller

Mayo Clinic (Cancer Clinical Research Office)

Recruiting

Jacksonville,Florida,32224-1865,United States

Candido Rivera

Northwestern Memorial Hospital (Oncology)

Recruiting

Chicago,Illinois,60611-5957,United States

Brady Stein

UMHS - University of Michigan Medical Center (Radiation Oncology)

Recruiting

Ann Arbor,Michigan,48109-5000,United States

Moshe Talpaz

Mount Sinai Hospital - Oncology

Recruiting

New York,New York,10029,United States

Marina Kremyanskaya

Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)

Recruiting

New York,New York,10065,United States

Joseph Scandura

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Medical Information


Source URL: https://prod1.novartis.com/clinicaltrials/study/nct06401356

List of links present in page
  1. https://clinicaltrials.gov/ct2/show/NCT06401356
  2. #trial-eligibility
  3. tel:+3250452310
  4. mailto:Jan.VanDroogenbroeck@azsintjan.be
  5. tel:+3232177257
  6. mailto:nikki.granacher@zna.be
  7. tel:+390557947824
  8. mailto:a.vannucchi@unifi.it
  9. tel:+390332393905
  10. mailto:marco.brociner@asst-settelaghi.it
  11. tel:+31650087564
  12. mailto:m.wondergem@amsterdamumc.nl
  13. tel:+4402071882742
  14. mailto:claire.harrison@gstt.nhs.uk
  15. tel:+442921827689
  16. mailto:knappers@cardiff.ac.uk
  17. tel:+4401413017231
  18. mailto:Mark.Drummond@ggc.scot.nhs.uk
  19. tel:+3107947538
  20. mailto:gschiller@mednet.ucla.edu
  21. tel:+19049532000
  22. mailto:rivera.candido@mayo.edu
  23. tel:+6305324724
  24. mailto:brady-stein@northwestern.edu
  25. tel:(+1)734-647-9913
  26. mailto:mtalpaz@med.umich.edu
  27. tel:(+1) 212-241-7012
  28. mailto:marina.kremyanskaya@mssm.edu
  29. tel:+12127462652
  30. mailto:jms2003@med.cornell.edu
  31. tel:+1 844 667-1992
  32. mailto:medinfo@morphosys.com