An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

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

Conditions

Hematologic Malignancy, Solid Tumor, Advanced Malignancies

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Study Overview

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Study Details

Study overview

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

An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Condition
Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Hematologic Malignancy/Stem (Department of Medicine, Division of Hematology/Oncology), Los Angeles, California, United States, 90095-8344

Jacksonville

Mayo Clinic (Cancer Clinical Research Office), Jacksonville, Florida, United States, 32224-1865

Chicago

Northwestern Memorial Hospital (Oncology), Chicago, Illinois, United States, 60611-5957

Ann Arbor

UMHS - University of Michigan Medical Center (Radiation Oncology), Ann Arbor, Michigan, United States, 48109-5000

New York

Mount Sinai Hospital - Oncology, New York, New York, United States, 10029

New York

Weill Cornell Medicine - New York Presbyterian Hospital (Oncology), New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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
  • 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
  • 1. Patients who are legally institutionalized or under judicial protection

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Constellation Pharmaceuticals,

Study Record Dates

2029-06-30