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Compares treatment options for Peripheral T Cell Lymphoma
Official title Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy
ClinicalTrials.gov ID: NCT07414758
What this study is testing
What is golidocitinib?
golidocitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peripheral t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to...
- Age \>18 years at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks.
- Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016)...
- people must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic...
You likely can't join if
- Patients with clinical stage Ann Arbor I disease.
- Any of the following treatment histories:
- Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose.
- Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose.
- Received systemic corticosteroid therapy at a dose \>10 mg prednisone equivalent per day within 1 week prior to the first study dose.
- Underwent major surgery (excluding vascular access procedures) or experienced significant trauma within 4 weeks prior to the first study dose, or has...
See the full eligibility criteria
Who can join
- The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and...
- Age \>18 years at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks.
- Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016). Eligible histological subtypes are limited to: PTCL-NOS (excluding...
- people must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic standard therapy (limited to CHOP, BV-CHP, or CHOP-like regimens), and...
- Adequate bone marrow and organ function, as defined below:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L in case of bone marrow involvement by lymphoma). people must not have used colony-stimulating factors within 7 days prior to study entry.
- Platelet count ≥100 × 10⁹/L (≥75 × 10⁹/L in case of bone marrow involvement by lymphoma). people must not have received transfusion or thrombopoietic agents within 7 days prior to study entry.
- Hemoglobin ≥10 g/dL.
- Total bilirubin ≤2 × Upper Limit of Normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
- Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL/min.
- Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO).
- Voluntarily participate in the clinical study; fully understand and are informed about this study and sign the ICF; willing and able to follow and complete all trial procedures.
What rules you out
- Patients with clinical stage Ann Arbor I disease.
- Any of the following treatment histories:
- Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose.
- Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose.
- Received systemic corticosteroid therapy at a dose \>10 mg prednisone equivalent per day within 1 week prior to the first study dose.
- Underwent major surgery (excluding vascular access procedures) or experienced significant trauma within 4 weeks prior to the first study dose, or has planned surgery during the study.
- Received antitumor monoclonal antibody therapy (including brentuximab vedotin) within 4 weeks; radiotherapy within 3 weeks; or other toxin/radioisotope-immunoconjugate therapy within 10 weeks prior to the first study...
- Prior treatment with a JAK or STAT3 inhibitor.
- Received antitumor immunotherapy (e.g., immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, anti-CTLA-4) within 28 days prior to the first study dose.
- Received live-attenuated or viral vector vaccines within 28 days prior to the first study dose.
- Current use (or inability to discontinue ≥1 week prior to the first dose) of vitamin K antagonists, antiplatelet agents, or anticoagulants. Current use (or inability to discontinue ≥1 week prior to the first dose) of...
- History of other active malignancies within the past 5 years, except for curatively treated localized cancers such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the...
- Active infection, including:
- Known active or latent tuberculosis, evidenced by a positive PPD skin test (\>10 mm induration, or per local clinical criteria) or findings suggestive of active/latent TB on chest X-ray/CT.
- Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Chronic active Hepatitis B or C infection, except:
- people positive for HBsAg or HBcAb are eligible if HBV-DNA is undetectable.
- people positive for HCV antibody are eligible if HCV-RNA is undetectable. (The ULN for HBV-DNA and HCV-RNA assays is defined per each center's laboratory standards.) (d) Other active viral infections (e.g., herpes...
- Poorly controlled or clinically significant cardiac disease, such as: i. Heart failure \> New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically...
- Pregnant or lactating women, or people of childbearing potential unwilling to use effective contraception.
- History of severe psychiatric disorders or inability to provide informed consent.
- people with refractory nausea, vomiting, or chronic gastrointestinal diseases that may impair drug absorption.
- Significant impairment of pulmonary function, defined as forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) \<60% of predicted.
- Presence of unresolved drug-related toxicities \> Grade 1 per CTCAE (except for alopecia) prior to the first study dose.
- Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.