Phase II Study on the Safety and Effectiveness of Golidocitinib for Newly Diagnosed Peripheral T Cell Lymphoma (GOLDEN Study)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06630091

Provider View

This study is testing whether the drug golidocitinib, used alone or with standard chemotherapy, can help control peripheral T cell lymphoma (PTCL) in newly diagnosed patients.

Patient Parameters

Program Overview

The main goal of this study is to see if golidocitinib can help patients with newly diagnosed peripheral T cell lymphoma (PTCL) live longer without the disease getting worse. Researchers will also look at how well the drug works in shrinking tumors and how safe it is for patients. Additionally, the study will explore which patients might benefit most from golidocitinib and investigate any resistance to the drug.

Description

This study aims to evaluate the effectiveness of golidocitinib in treating newly diagnosed peripheral T cell lymphoma (PTCL). The primary focus is on the 2-year progression-free survival rate, which means the length of time patients live without the disease worsening. Secondary goals include assessing how well the drug works in reducing tumor size and its safety based on reported side effects. Researchers will also explore potential biomarkers that could predict how well a patient responds to golidocitinib and investigate any resistance mechanisms.

Participants will need to provide a tumor sample for analysis and meet specific health criteria. The study will monitor the safety and tolerability of golidocitinib, with a focus on any adverse events. Participants will be required to use effective birth control during the study and for a period after completing the treatment, due to potential risks to unborn children. Both men and women must agree to these precautions, and those wishing to have children in the future may consider preserving eggs or sperm before starting the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide written consent to participate.
  • Must submit a tumor sample for analysis.
  • Must have a confirmed diagnosis of peripheral T cell lymphoma (PTCL) by a specific medical review.
  • Must have measurable disease based on specific criteria.
  • Must not have received any prior treatment for T-cell lymphoma.
  • Must have adequate bone marrow and organ function.
  • Must have a life expectancy of at least 12 weeks.
  • Must agree to use effective contraception during the study and for a specified period after.
  • Must be able to comply with study procedures and follow-up visits.

Exclusion Criteria

  • Cannot have received certain cancer treatments or medications before the study.
  • Cannot have central nervous system lymphoma.
  • Cannot have severe lung conditions or a history of certain lung diseases.
  • Cannot have active infections like tuberculosis, HIV, or hepatitis.
  • Cannot have certain heart conditions or recent heart issues.
  • Cannot have another active cancer within the last 5 years, except for specific types.
  • Cannot have severe nausea or gastrointestinal issues that affect drug absorption.
  • Cannot have allergies to golidocitinib or similar drugs.
  • Cannot have uncontrolled systemic diseases or conditions that affect study compliance.
  • Cannot be pregnant or breastfeeding due to potential risks to the baby.

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