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Trial Title:
An Extension Study for Patients Previously Enrolled in Studies with Pelabresib
NCT ID:
NCT06401356
Condition:
Hematologic Malignancy
Solid Tumor
Advanced Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pelabresib
Description:
Small molecule inhibitor of bromodomain and extraterminal (BET) protein
Arm group label:
No arm title
Other name:
CPI-0610
Summary:
The purpose of this study is to provide continued access to treatment with pelabresib for
patients who previously received pelabresib in a parent study and to continue collecting
safety and efficacy information. By collecting efficacy information, the study team
monitors if pelabresib helps the patient with their disease. Additionally, survival
follow-up data will be collected. Survival follow-up collects information on the
patient's leukemia-free survival and overall survival status (life span) during and after
the treatment is ended. If a patient stopped pelabresib treatment on the parent study for
any other reason than participation in this study, they will not receive further
pelabresib treatment, but they can enter the study for survival-follow up only.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Weill Medical College and New York Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Penina Stewart
Phone:
212-746-5454
Email:
pes4006@med.cornell.edu
Start date:
August 13, 2024
Completion date:
June 30, 2029
Lead sponsor:
Agency:
Constellation Pharmaceuticals
Agency class:
Industry
Source:
Constellation Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06401356
