Maintenance Treatment of Peripheral T-cell LymphomaPhase 3T-START-M1NCT07300514
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
A Phase 3 study testing PET-CTandct- DNAdetection and golidocitinib in people with Maintenance Treatment of Peripheral T-cell Lymphoma, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maintenance Treatment of Peripheral T-cell Lymphoma
- What is being tested?
- PET-CTandct- DNAdetection and golidocitinib
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 30 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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).
- Hepatitis B virus (HBV) DNA ≥1000 IU/mL or other HBV status not meeting protocol-defined criteria for safe inclusion.
- 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.
- History of drug-induced interstitial lung disease or current evidence of clinically significant interstitial lung disease.
- Pregnant or breastfeeding women; women of childbearing potential and men with fertile partners who are unwilling or unable to use effective contraception during treatment and for the protocol-specified period after the last dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Rong Tao, MD & PhD, 0086-21-64175590, rtao@shca.org.cn
Chuanxu Liu, MD & PhD, 0086-21-64175590, liuchuanxu@shca.org.cn
About this study
Official title: Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma in Complete or Partial Remission After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Phase III Clinical Study.
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.
Read the detailed description
Peripheral T-cell lymphomas (PTCL) are aggressive non-Hodgkin lymphomas with poor prognosis and high relapse rates after first-line chemotherapy. There is no established standard of care for post-remission maintenance therapy in patients who are not candidates for hematopoietic stem cell transplantation. Aberrant activation of the JAK/STAT pathway plays a critical role in the pathogenesis and progression of PTCL. Golidocitinib (Chinese name: 戈利昔替尼) is an oral, potent, and highly selective JAK1 inhibitor that has demonstrated robust antitumor activity and a favorable safety profile in relapsed or refractory PTCL in prior clinical studies, leading to its recommended phase II dose of 150 mg once daily.
Based on these data and the unmet need for effective maintenance strategies, this phase III study (T-START-M1) will enroll adult patients with histologically confirmed PTCL subtypes (PTCL-NOS excluding primary cutaneous disease, ALK-ALCL, AITL, FTCL/PTCL-TFH) who achieved CR or PR after first-line CHOP, BV-CHP, or CHOP-like regimens and are ineligible for HSCT (age >65 years) or decline HSCT despite eligibility. Randomization (1:1) will be stratified by initial response status (CR vs PR), histologic subtype (ALK-ALCL vs others), and HSCT eligibility (ineligible vs eligible-but-declining).
Participants will receive golidocitinib 150 mg every other day or matching placebo in 28-day cycles for up to 24 months. Tumor response will be assessed by imaging according to Lugano 2014 criteria, and ctDNA-based MRD will be evaluated at baseline, 12 months, and end of treatment. Patients who achieve complete metabolic response plus MRD negativity at 12 months may stop maintenance, while others continue up to 2 years. After treatment discontinuation, patients will be followed for progression, subsequent anti-lymphoma therapies, and survival for up to approximately 13 additional cycles (about 1 year). The primary objective is to determine whether golidocitinib maintenance improves PFS compared with placebo. Key secondary objectives include evaluation of overall survival, complete response rate, duration of response, time to next anti-lymphoma therapy, ctDNA-based MRD dynamics, and safety including incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and grade ≥3 AEs.
- Being tested
- PET-CTandct- DNAdetection, golidocitinib, Placebo
- Keywords
- Peripheral T-cell lymphoma, ALK-positive anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, TFH phenotype PTCL, Golidocitinib, JAK1 inhibitor, Maintenance therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTandct- DNAdetectionDevice
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.
golidocitinibDrug
golidocitinib maintenance treatment given orally as 150mg every other day
PlaceboDrug
Placebo given orally as 150mg every other day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: PET-CTandct- DNAdetection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Time from randomization to death from any cause.
Measured: From randomization until death from any cause, up to approximately 5 years.
Complete Response Rate (CRR)
Proportion of patients achieving complete response (CR) according to Lugano 2014 criteria.
Measured: From randomization to end of treatment, up to 24 months.
Duration of Response (DOR)
Duration of response among patients who achieve CR or PR.
Measured: 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)
ime from randomization to the first administration of subsequent anti-lymphoma therapy or death.
Measured: 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
Proportion of patients who achieve minimal residual disease (MRD)-negative status by ctDNA assessment at 12 months.
Measured: 12 months after randomization.
Incidence of Treatment-emergent Adverse Events (TEAEs)
Number and percentage of patients experiencing TEAEs, serious adverse events (SAEs), grade ≥3 AEs, AEs leading to dose interruption, dose reduction, or treatment discontinuation.
Measured: From first dose of study drug to 28 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start27 Mar 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maintenance Treatment of Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized 1:1 to golidocitinib or placebo as maintenance therapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD &PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300514
- Sponsor's protocol ID
- T-START-M1-2025
- Acronym
- T-START-M1
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29599200Maurer 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.
PubMed 29072976Park 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.
PubMed 30694529Maurer 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.
PubMed 31123029Cooley 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.
PubMed 25482745Cheson 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.
PubMed 25113753Armitage JO. The aggressive peripheral T-cell lymphomas: 2017. Am J Hematol. 2017 Jul;92(7):706-715. doi: 10.1002/ajh.24791.
PubMed 28516671
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma in Complete or Partial Remission After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Phase III Clinical Study.
- ClinicalTrials.gov ID
- NCT07300514
- Acronym / sponsor ID
- T-START-M1 / T-START-M1-2025
- Keywords
- Peripheral T-cell lymphoma, ALK-positive anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, TFH phenotype PTCL, Golidocitinib, JAK1 inhibitor, Maintenance therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral T-cell lymphomas (PTCL) are aggressive non-Hodgkin lymphomas with poor prognosis and high relapse rates after first-line chemotherapy. There is no established standard of care for post-remission maintenance therapy in patients who are not candidates for hematopoietic stem cell transplantation. Aberrant activation of the JAK/STAT pathway plays a critical role in the pathogenesis and progression of PTCL. Golidocitinib (Chinese name: 戈利昔替尼) is an oral, potent, and highly selective JAK1 inhibitor that has demonstrated robust antitumor activity and a favorable safety profile in relapsed or refractory PTCL in prior clinical studies, leading to its recommended phase II dose of 150 mg once daily.
Based on these data and the unmet need for effective maintenance strategies, this phase III study (T-START-M1) will enroll adult patients with histologically confirmed PTCL subtypes (PTCL-NOS excluding primary cutaneous disease, ALK-ALCL, AITL, FTCL/PTCL-TFH) who achieved CR or PR after first-line CHOP, BV-CHP, or CHOP-like regimens and are ineligible for HSCT (age >65 years) or decline HSCT despite eligibility. Randomization (1:1) will be stratified by initial response status (CR vs PR), histologic subtype (ALK-ALCL vs others), and HSCT eligibility (ineligible vs eligible-but-declining).
Participants will receive golidocitinib 150 mg every other day or matching placebo in 28-day cycles for up to 24 months. Tumor response will be assessed by imaging according to Lugano 2014 criteria, and ctDNA-based MRD will be evaluated at baseline, 12 months, and end of treatment. Patients who achieve complete metabolic response plus MRD negativity at 12 months may stop maintenance, while others continue up to 2 years. After treatment discontinuation, patients will be followed for progression, subsequent anti-lymphoma therapies, and survival for up to approximately 13 additional cycles (about 1 year). The primary objective is to determine whether golidocitinib maintenance improves PFS compared with placebo. Key secondary objectives include evaluation of overall survival, complete response rate, duration of response, time to next anti-lymphoma therapy, ctDNA-based MRD dynamics, and safety including incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and grade ≥3 AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to golidocitinib or placebo as maintenance therapy.
| Arm | Type | Receives |
|---|---|---|
| Arm A - Experimental: Golidocitinib | Experimental | Device: PET-CTandct- DNAdetection, Drug: golidocitinibParticipants 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. |
| Arm B - Placebo Comparator: Placebo | Placebo comparator | Device: PET-CTandct- DNAdetection, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (18 listed)
- Ann Arbor stage I disease at initial diagnosis.
- Prior treatments that could interfere with study therapy, including but not limited to:
- Active hepatitis C infection (positive anti-HCV antibody).
- Hepatitis B virus (HBV) DNA ≥1000 IU/mL or other HBV status not meeting protocol-defined criteria for safe inclusion.
- Known HIV infection with confirmed positive serology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CTandct- DNAdetectionThe 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. | Device | Arm A - Experimental: Golidocitinib, Arm B - Placebo Comparator: Placebo |
| golidocitinibgolidocitinib maintenance treatment given orally as 150mg every other day | Drug | Arm A - Experimental: Golidocitinib |
| PlaceboPlacebo given orally as 150mg every other day | Drug | Arm B - Placebo Comparator: Placebo |
Primary outcome
Progression-free Survival (PFS)
Time frame: From randomization to the first documentation of disease progression, relapse, or death from any cause, up to approximately 3 years.
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.
6 secondary outcomes
Overall Survival (OS)
Time frame: From randomization until death from any cause, up to approximately 5 years.
Complete Response Rate (CRR)
Time frame: From randomization to end of treatment, up to 24 months.
Duration of Response (DOR)
Time frame: 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)
Time frame: 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
Time frame: 12 months after randomization.
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug to 28 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 29599200Bellei 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.
- Results publication: PubMed 29072976Maurer 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.
- Results publication: PubMed 30694529Park 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.
- Results publication: PubMed 31123029Maurer 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.
- Results publication: PubMed 25482745Cooley 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.
- Results publication: PubMed 25113753Cheson 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.
- Results publication: PubMed 28516671Armitage JO. The aggressive peripheral T-cell lymphomas: 2017. Am J Hematol. 2017 Jul;92(7):706-715. doi: 10.1002/ajh.24791.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Tao, MD &PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET-CTandct- DNAdetection and golidocitinib in people with Maintenance Treatment of Peripheral T-cell Lymphoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tao, MD & PhD (0086-21-64175590, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: From randomization to the first documentation of disease progression, relapse, or death from any cause, up to approximately 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07300514, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.