RecruitingPhase 2NCT06630091
A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study
Sponsor
M.D. Anderson Cancer Center
Enrollment
30 participants
Start Date
Feb 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This Phase II study (called GOLDEN) is testing whether a drug called golidocitinib — which blocks a protein involved in cancer cell growth — is safe and effective as a first-line treatment for a group of aggressive blood cancers called peripheral T-cell lymphoma (PTCL).
**You may be eligible if...**
- You are 18 or older
- You have been newly diagnosed with specific subtypes of peripheral T-cell lymphoma (including PTCL-NOS, AITL, follicular T-cell lymphoma, or TFH phenotype)
- You have not yet received any treatment for this lymphoma
- You have at least one measurable tumor
- Your overall health is reasonably good (ECOG 0-2)
**You may NOT be eligible if...**
- You have previously received chemotherapy or JAK/STAT inhibitors for this cancer
- You have CNS (brain/spinal) lymphoma
- You have active TB, HIV, or active hepatitis B or C
- You have significant heart problems including recent heart attack or dangerous heart rhythms
- You are pregnant or breastfeeding
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGGolidocitinib
150 mg once per day by PO
DRUGCyclophosphamide
750 mg/m2 by IV
DRUGDoxorubicin
50 mg/m2 by IV
DRUGVincristine
1.4 mg/m2 (max: 2 mg) by IV
DRUGPrednisone
100 mg by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06630091
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