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.

Condition

Hematologic Malignancy, Solid Tumor, Advanced Malignancies

Phase

Phase3

Overall Status

Recruiting

Number of Participants

Start Date

Aug 13, 2024

Completion Date

Jun 30, 2029

Gender

All

Age(s)

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