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

NCT06630091 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-0517NCI-2024-08417
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

  Through study completion; an average of 1 year

Study Arms (1)

Golidocitinib + CHOP

EXPERIMENTAL

Golidocitinib will be administered at 150 mg PO daily as monotherapy unless dose modified per toxicity chart; when in combination with CHOP, the maximum dose of golidocitinib is 150 mg PO every other day

Drug: Golidocitinib; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Golidocitinib DRUG

150 mg once per day by PO

Golidocitinib + CHOP

Cyclophosphamide DRUG

750 mg/m2 by IV

Golidocitinib + CHOP

Doxorubicin DRUG

50 mg/m2 by IV

Golidocitinib + CHOP

Vincristine DRUG

1.4 mg/m2 (max: 2 mg) by IV

Golidocitinib + CHOP

Prednisone DRUG

100 mg by PO

Golidocitinib + CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Luis Malpica Castillo, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Malpica Castillo, MD

CONTACT

713-563-8954; lemalpica@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): July 5, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)