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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06401356
Other study ID # CNST0610C210
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Constellation Pharmaceuticals
Contact Medical Information
Phone +1 844 667-1992
Email medinfo@morphosys.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Pelabresib
Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Constellation Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: TEAEs and Serious TEAEs Occurrence and severity of treatment-emergent adverse events (TEAEs) and serious TEAEs among patients who are receiving pelabresib 5 years
Primary Survival Overall survival and leukemia-free survival 5 years
Primary Time to event endpoints Time to event endpoints (eg, duration of response, progression-free survival) in patients who are receiving or received pelabresib 5 years
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