Clinical trial NCT06401356: An Extension Study for Patients Previously Enrolled in Studies with Pelabresib
Official title: An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies with Pelabresib
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hematologic Malignancy
Solid Tumor
Advanced Malignancies
Lead sponsor: Constellation Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

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

Primary outcomes:
measure: Safety: TEAEs and Serious TEAEs
timeFrame: 5 years
measure: Survival
timeFrame: 5 years
measure: Time to event endpoints
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology)
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic (Cancer Clinical Research Office)
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital (Oncology)
state: Illinois
city: Ann Arbor
country: United States
facility: UMHS - University of Michigan Medical Center (Radiation Oncology)
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital - Oncology
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - New York Presbyterian Hospital (Oncology)
state: New York
city: Antwerpen
country: Belgium
facility: ZNA Cadix-Hematology
city: Brugge
country: Belgium
facility: Az St-Jan Brugge-Oostende A.V.
city: Firenze
country: Italy
facility: AOU Careggi (Department of Experimental and Clinical Medicine)
city: Novara
country: Italy
facility: Azienda Ospedaliero - Universitaria Maggiore della Carità (SCDU Ematologia)
city: Varese
country: Italy
facility: AO Ospedale di Circolo, PO Varese (Ematologia)
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location Vumc (Hematology)
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board - University Hospital Wales (Hematology)
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre (Hematology)
city: London
country: United Kingdom
facility: Guys and St Thomas' Hospital - Haematology
Study officials:
References: