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

Recruiting now · Phase 2

Conditions studied: Peripheral T Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT06630091

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2025-02-21

Expected to finish

2029-07-05

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of a signed and dated, written informed consent form prior to any study specific procedures, sampling, and analyses.
• Submission of the tumor block or unstained slides from an excisional or core biopsy from nodal or extra-nodal lymphoma tissue (archived or newly obtained sample) is required for retrospective central confirmation of tumor histological subtype.
• Aged ≥ 18 years old.
• Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks.
• Predicted life expectancy ≥ 12 weeks.
• Participants must have histologically confirmed peripheral T-cell lymphoma by MD Anderson pathology review according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms53. Eligible histological subtypes are restricted to the following:
• PTCL, not otherwise specified (PTCL, NOS) (the proportion of PTCL-NOS subtype will not exceed 30% of all enrolled)
• Angioimmunoblastic T-cell lymphoma (AITL)
• Follicular T cell lymphoma
• PTCL with T follicular helper (TFH) phenotype
• Participants must have measurable disease according to the 2014 Lugano classification, which is defined as lymphomatous nodes, nodal masses, or other lymphomatous lesions are measurable in two diameters (longest diameter [LDi] and shortest diameter perpendicular to the LDi [SDi]) on CT scans, and also with LDi as below:
• A measurable node must have an LDi greater than 1.5 cm.
• A measurable extranodal lesion should have an LDi greater than 1.0 cm.
• Participants must be treatment naïve with no prior systemic treatment for T-cell lymphoma (i.e., PTCL). Participants could be transplant eligible or ineligible upon their entries to this study.
• Adequate bone marrow reserve and organ system functions, as outlined below:
• Absolute neutrophil count (ANC) ≥ 1 ×109/L (≥0.5 ×109/L if documented bone marrow involvement with lymphoma) independent of growth factor support within 7 days of study entry.
• Platelets ≥ 75 × 109/L (or ≥ 50 × 109/L if documented bone marrow involvement with lymphoma) independent of growth factor support or transfusion within 7 days of study entry.
• Hemoglobin ≥ 8 g/dL
• Total bilirubin ≤ 1.5 ×ULN if no liver involvement or ≤ 3 ×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver involvement.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 ×ULN if with document hepatic involvement with lymphoma.
• Creatinine ≤ 1.5 × ULN, OR calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL/min.
• LVEF ≥ 50% assessed by ECHO or MUGA.
• Participants should have the ability and willingness to comply with the study and follow up.
• The effects of golidocitinib on the developing human fetus are unknown. For this reason and because JAK1 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).

You may not qualify if…

• Participants must not enter the study if any of the following exclusion criteria are fulfilled:
• Intervention with any of the following:
• Any investigational anti-cancer agents or anti-cancer study drugs from a previous clinical study.
• Any cytotoxic chemotherapy from a previous treatment regimen.
• Corticosteroids at dosages equivalent to prednisone > 40 mg/day within 7 days of the start of the study treatment.
• Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
• Prior treatment with a JAK or STAT3 inhibitor.
• Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of golidocitinib (e.g., immune checkpoint inhibitors PD-1, PD-L1, CTLA4).
• Live vaccines within 28 days prior to first dose.
• Participants currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be Potent inhibitors or inducers of CYP3A .
• Central nervous system or leptomeningeal lymphoma given the lack of evidence of CNS penetrance of the investigational drug.
• Participants with severely decreased lung function (i.e. any parameter of FEV1, and DLCO < 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
• Participants with disease condition which requires the treatment of immunosuppressants, biologics, or NSAIDs (non-steroid anti-inflammatory drugs).
• Active infections including
• History of known active tuberculosis (TB).
• Known infection with human immunodeficiency virus (HIV).
• Known active hepatitis B or hepatitis C infection as follows
• Active viral infections (i.e., zoster) other than hepatitis B or C.
• o Infections requiring oral or intravenous antimicrobial therapy or interferon within 14 days.
• Any of the following cardiac criteria:
• Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II .
• Clinically significant valvular diseases, hypertrophic or constrictive cardiomyopathy.
• Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Acute Myocardial Infarction (AMI) within 6 months prior to starting treatment, unstable angina or new-onset angina.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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