Extension Study for Patients Previously in Pelabresib Trials

Sponsor: Constellation Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06401356

Provider View

This study offers continued access to the drug pelabresib for patients who were part of earlier trials and aims to gather more information on its safety and effectiveness. It also tracks the survival of patients who stopped taking pelabresib or a placebo in previous studies.

Patient Parameters

Program Overview

The study is designed to allow patients who were part of earlier pelabresib trials to keep receiving the drug and to continue monitoring its safety and effectiveness. Researchers will collect data on how well pelabresib works in controlling the disease and any side effects it may cause. Additionally, the study will follow up on patients' survival, including those who stopped taking pelabresib or a placebo in previous studies, to understand their overall and leukemia-free survival rates.

Description

This extension study provides ongoing access to pelabresib for patients who were part of earlier trials and continue to benefit from the treatment. The study will keep track of how well pelabresib works in managing the disease and any side effects that occur. Researchers will also gather information on patients' survival, including those who stopped taking pelabresib or a placebo in previous studies, to assess their overall and leukemia-free survival.

Patients who stopped taking pelabresib in the earlier study for reasons other than joining this extension study will not receive pelabresib here, but they can still participate in the survival follow-up. This follow-up will collect data on how long patients live and how long they remain free from leukemia after stopping treatment.

Eligibility Criteria

Inclusion Criteria

Eligibility for Continuing Pelabresib Treatment

  • Able to provide informed consent
  • Benefiting from pelabresib treatment in the previous study
  • Willing and able to attend scheduled visits and follow the treatment plan

Eligibility for Survival Follow-up

  • Able to provide informed consent
  • At least 18 years old and of legal consenting age
  • Previously enrolled in a pelabresib clinical study
  • Willing and able to participate in ongoing follow-up

Exclusion Criteria

Eligibility for Continuing Pelabresib Treatment

  • Legally institutionalized or under judicial protection
  • Any medical condition that makes participation unsuitable
  • Able to access pelabresib outside the study
  • Uncontrolled illness or condition that could affect safety or compliance
  • Pregnant or breastfeeding women

Eligibility for Survival Follow-up

  • Legally institutionalized or under judicial protection

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.