Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma

NCT07300514 | Recruiting Phase 3 DMC

• 1 other identifier: T-START-M1-2025
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or partial response (PR) after first-line systemic chemotherapy and are not candidates for hematopoietic stem cell transplantation (HSCT) or decline HSCT. Eligible patients with histologically confirmed PTCL subtypes (PTCL-NOS, ALK-positive anaplastic large cell lymphoma \[ALK-ALCL\], angioimmunoblastic T-cell lymphoma \[AITL\], or follicular helper T-cell phenotype PTCL \[FTCL/PTCL-TFH\]) according to the 2016 WHO classification will be randomized 1:1 to receive oral golidocitinib or matching placebo. Study treatment is given at 150 mg every other day in 28-day cycles for up to 2 years or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination. At 12 months, patients who achieve complete metabolic response on PET-CT and minimal residual disease (MRD)-negative status by ctDNA may discontinue maintenance, whereas others continue treatment up to 24 months. After treatment discontinuation, patients will be followed for disease status and survival for up to approximately 13 additional cycles. The primary endpoint is progression-free survival (PFS) assessed by investigators per Lugano 2014 criteria. Key secondary endpoints include overall survival, response rates, duration of response, time to next anti-lymphoma therapy, MRD dynamics by ctDNA, and safety.

Conditions

Maintenance Treatment of Peripheral T-cell Lymphoma

Keywords

Peripheral T-cell lymphoma; ALK-positive anaplastic large cell lymphoma; Angioimmunoblastic T-cell lymphoma; TFH phenotype PTCL; Golidocitinib; JAK1 inhibitor; Maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS is defined as the time from randomization to the first documented disease progression or relapse according to Lugano 2014 criteria, or death from any cause, whichever occurs first, as assessed by investigators. A blinded independent central review (BICR) will perform a sensitivity analysis of PFS to assess robustness.

  From randomization to the first documentation of disease progression, relapse, or death from any cause, up to approximately 3 years.

Secondary Outcomes (6)

• Overall Survival (OS)

  From randomization until death from any cause, up to approximately 5 years.

• Complete Response Rate (CRR)

  From randomization to end of treatment, up to 24 months.

• Duration of Response (DOR)

  From the first documented response (CR or PR) to disease progression, relapse, or death, up to approximately 3 years.

• Time to Next Anti-lymphoma Therapy (TTNT)

  From randomization to the start of the next systemic anti-lymphoma therapy or death, up to approximately 3 years.

• MRD Negativity Rate by ctDNA at 12 Months

  12 months after randomization.

Study Arms (2)

Arm A - Experimental: Golidocitinib

EXPERIMENTAL

Participants receive golidocitinib 150 mg orally every other day in 28-day cycles for up to 24 months, or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination.

Device: PET-CTandct- DNAdetection; Drug: golidocitinib

Arm B - Placebo Comparator: Placebo

PLACEBO COMPARATOR

Participants receive matching placebo capsules orally every other day in 28-day cycles for up to 24 months, or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination.

Device: PET-CTandct- DNAdetection; Drug: Placebo

Interventions

PET-CTandct- DNAdetection DEVICE

The patients who achieved CMR by PET-CT and MRD-neg by ct-DNA testing were evaluated at 12 months,One patient stopped maintenance treatment, while the rest continued for one year.

Arm A - Experimental: Golidocitinib; Arm B - Placebo Comparator: Placebo

golidocitinib DRUG

golidocitinib maintenance treatment given orally as 150mg every other day

Arm A - Experimental: Golidocitinib

Placebo DRUG

Placebo given orally as 150mg every other day

Arm B - Placebo Comparator: Placebo

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements.
• Age ≥18 years at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening.
• Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding primary cutaneous PTCL), ALK-positive anaplastic large cell lymphoma (ALK-ALCL), angioimmunoblastic T-cell lymphoma (AITL), or T-follicular helper phenotype PTCL (FTCL or PTCL-TFH).
• Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens, as assessed by Lugano 2014 criteria; patients must be ineligible for HSCT (age \>65 years) or eligible but decline HSCT (age ≤65 years). The interval between completion of first-line therapy and planned first dose in this study must be ≤3 months.
• Adequate bone marrow and organ function, including:
• Absolute neutrophil count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow is involved by lymphoma), without use of colony-stimulating factors within 7 days before study entry.
• Platelet count ≥100×10⁹/L (≥75×10⁹/L if bone marrow is involved by lymphoma), without transfusion or platelet growth factors within 7 days before study entry.
• Hemoglobin ≥10 g/dL.
• Total bilirubin ≤2× upper limit of normal (ULN).
• ALT and AST ≤2.5×ULN.
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated or measured).
• Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
• Willingness and ability to comply with study procedures and follow-up.

You may not qualify if:

• Ann Arbor stage I disease at initial diagnosis.
• Prior treatments that could interfere with study therapy, including but not limited to:
• Investigational agents or antineoplastic drugs within 30 days before first study dose.
• Cytotoxic chemotherapy within 21 days before first study dose.
• Systemic corticosteroids at a prednisone-equivalent dose \>10 mg/day within 7 days before first study dose.
• Major surgery (excluding vascular access procedures) or severe trauma within 4 weeks before first study dose, or planned surgery during study treatment.
• Antineoplastic monoclonal antibodies (including brentuximab vedotin) within 4 weeks before first study dose; radiotherapy within 3 weeks; other toxin- or radioisotope-conjugated antibodies within 10 weeks.
• Prior treatment with any JAK or STAT3 inhibitor.
• Antitumor immunotherapy (e.g., immune checkpoint inhibitors including PD-1, PD-L1, CTLA-4 antibodies) within 28 days before first study dose.
• Live attenuated or viral vector vaccines within 28 days before first study dose.
• Current use of vitamin K antagonists, antiplatelet or anticoagulant drugs that cannot be discontinued ≥7 days before first study dose.
• Concomitant medications that are strong CYP3A inducers or inhibitors, or BCRP/P-gp substrates with narrow therapeutic index that cannot be stopped ≥7 days before first study dose, as specified in the protocol appendix.
• Active hepatitis C infection (positive anti-HCV antibody).
• Known HIV infection with confirmed positive serology.
• Any uncontrolled, clinically significant comorbidities or laboratory abnormalities that, in the investigator's judgment, would increase risk or interfere with study participation.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Related Publications (7)

• Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M; International T-cell Project Network. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica. 2018 Jul;103(7):1191-1197. doi: 10.3324/haematol.2017.186577. Epub 2018 Mar 29.

  PMID: 29599200 BACKGROUND

• Maurer MJ, Ellin F, Srour L, Jerkeman M, Bennani NN, Connors JM, Slack GW, Smedby KE, Ansell SM, Link BK, Cerhan JR, Relander T, Savage KJ, Feldman AL. International Assessment of Event-Free Survival at 24 Months and Subsequent Survival in Peripheral T-Cell Lymphoma. J Clin Oncol. 2017 Dec 20;35(36):4019-4026. doi: 10.1200/JCO.2017.73.8195. Epub 2017 Oct 26.

  PMID: 29072976 RESULT

• Park SI, Horwitz SM, Foss FM, Pinter-Brown LC, Carson KR, Rosen ST, Pro B, Hsi ED, Federico M, Gisselbrecht C, Schwartz M, Bellm LA, Acosta M, Advani RH, Feldman T, Lechowicz MJ, Smith SM, Lansigan F, Tulpule A, Craig MD, Greer JP, Kahl BS, Leach JW, Morganstein N, Casulo C, Shustov AR; COMPLETE Investigators. The role of autologous stem cell transplantation in patients with nodal peripheral T-cell lymphomas in first complete remission: Report from COMPLETE, a prospective, multicenter cohort study. Cancer. 2019 May 1;125(9):1507-1517. doi: 10.1002/cncr.31861. Epub 2019 Jan 29.

  PMID: 30694529 RESULT

• Maurer B, Nivarthi H, Wingelhofer B, Pham HTT, Schlederer M, Suske T, Grausenburger R, Schiefer AI, Prchal-Murphy M, Chen D, Winkler S, Merkel O, Kornauth C, Hofbauer M, Hochgatterer B, Hoermann G, Hoelbl-Kovacic A, Prochazkova J, Lobello C, Cumaraswamy AA, Latzka J, Kitzwogerer M, Chott A, Janikova A, Pospisilova S, Loizou JI, Kubicek S, Valent P, Kolbe T, Grebien F, Kenner L, Gunning PT, Kralovics R, Herling M, Muller M, Rulicke T, Sexl V, Moriggl R. High activation of STAT5A drives peripheral T-cell lymphoma and leukemia. Haematologica. 2020 Jan 31;105(2):435-447. doi: 10.3324/haematol.2019.216986. Print 2020.

  PMID: 31123029 RESULT

• Cooley L, Dendle C, Wolf J, Teh BW, Chen SC, Boutlis C, Thursky KA. Consensus guidelines for diagnosis, prophylaxis and management of Pneumocystis jirovecii pneumonia in patients with haematological and solid malignancies, 2014. Intern Med J. 2014 Dec;44(12b):1350-63. doi: 10.1111/imj.12599.

  PMID: 25482745 RESULT

• Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

  PMID: 25113753 RESULT

• Armitage JO. The aggressive peripheral T-cell lymphomas: 2017. Am J Hematol. 2017 Jul;92(7):706-715. doi: 10.1002/ajh.24791.

  PMID: 28516671 RESULT

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy

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; Lymphadenopathy

Study Officials

• Rong Tao, MD &PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD & PhD

CONTACT

0086-21-64175590; rtao@shca.org.cn

Chuanxu Liu, MD & PhD

CONTACT

0086-21-64175590; liuchuanxu@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind treatment; golidocitinib and placebo are identical in appearance. Tumor assessments are evaluated by investigators and a blinded independent central review (BICR).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized 1:1 to golidocitinib or placebo as maintenance therapy.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)