Actively Recruiting
A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in Newly Diagnosed Peripheral T Cell Lymphoma Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating golidocitinib, given alone or with the standard CHOP chemotherapy, in patients newly diagnosed with peripheral T-cell lymphoma (PTCL). This phase II study aims to assess how well golidocitinib controls the disease by measuring progression-free survival over two years, along with other measures of tumor response and safety. The study also explores biomarkers in tumor and plasma samples to understand response and resistance mechanisms. The treatment involves giving golidocitinib orally at 150 mg daily as a single agent or every other day when combined with CHOP chemotherapy, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone. Dose adjustments may be made based on side effects. This single-center, single-arm study monitors participants throughout treatment and evaluates them with imaging and clinical assessments. Participants will undergo regular evaluations including imaging with PET/CT scans to assess tumor response, blood tests for safety and biomarker analysis, and monitoring for side effects graded by standard criteria. The main outcome is safety and adverse events tracked over about one year. The study requires participant commitment to follow-up visits and adherence to study procedures, with an overall participation period extending to the study completion around 2029.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Submission of tumor samples for confirmation of lymphoma subtype
- Age 18 years or older
- ECOG performance status 0 to 2 without recent worsening
- Predicted life expectancy of at least 12 weeks
- Histologically confirmed peripheral T-cell lymphoma with specified subtypes
- Measurable disease per 2014 Lugano classification criteria
- No prior systemic treatment for T-cell lymphoma
- Adequate bone marrow and organ function as defined by specific lab values
- Left ventricular ejection fraction (LVEF) of at least 50%
- Ability and willingness to comply with study procedures
- Use of effective contraception for women of child-bearing potential and men during and after study participation
You will not qualify if you...
- Previous treatment with investigational anti-cancer agents or chemotherapy
- Use of corticosteroids over prednisone 40 mg/day within 7 days before treatment
- Major surgery or significant injury within 4 weeks before treatment
- Prior treatment with JAK or STAT3 inhibitors
- Prior onco-immunotherapy within 28 days before golidocitinib
- Recent live vaccines within 28 days before treatment
- Use of strong CYP3A inhibitors or inducers within 1 week before treatment
- Central nervous system or leptomeningeal lymphoma
- Severely decreased lung function or active interstitial lung disease
- Conditions requiring immunosuppressants, biologics, or NSAIDs
- Active infections including tuberculosis, HIV, hepatitis B or C, or other viral infections
- Significant cardiac conditions including heart failure, arrhythmias, recent heart attack, or abnormal ECG findings
- History of another malignancy within 5 years except certain treated cancers
- Severe nausea/vomiting or gastrointestinal conditions affecting drug absorption
- Hypersensitivity to golidocitinib or similar drugs
- Severe uncontrolled systemic diseases
- Psychiatric or social conditions limiting study compliance
- Pregnancy or breastfeeding due to potential risks of golidocitinib
- Use of medications or foods that strongly affect CYP3A enzyme activity
- Psychiatric illness or social situations limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive golidocitinib combined with CHOP chemotherapy to treat newly diagnosed peripheral T-cell lymphoma.
Regular visits for treatment and safety monitoring according to protocol
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Luis Malpica Castillo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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