Go-CHOP as the Frontline Therapy for PTCL

Last updated: August 29, 2023
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

CHOP Regimen

Golidocitinib

Clinical Study ID

NCT05963347
DZ2022J0003
  • Ages > 18
  • All Genders

Study Summary

This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must sign an informed consent form prior to trial-specific procedures,sampling, and analysis.
  2. Participants must be at least 18 years of age (inclusive) at the time of signing theinformed consent form.
  3. The participant has an ECOG performance status of 0 to 2 and has not deteriorated inthe past 2 weeks.
  4. Life expectancy ≥ 3 months.
  5. Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphomatherapy; and assessed by a local pathologist according to the 2016 revised WorldHealth Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) asthe following subtypes:
  • peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
  • angioimmunoblastic T cell lymphoma (AITL)
  • follicular T-cell lymphoma (FTCL)
  • nodular PTCL with follicular helper T-cell phenotype (nodular PTCL with TFHphenotype)
  • ALK- anaplastic large cell lymphoma (ALK- ALCL)
  • ALK+ anaplastic large cell lymphoma (ALK + ALCL)
  • enteropathy-associated T-cell lymphoma (EATL)
  • monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
  • hepatosplenic T-cell lymphoma (HSTCL)
  • subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
  1. Adequate bone marrow reserve and organ system function reserve
  2. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO.
  3. Participants should be able and willing to comply with the study protocol requirement.
  4. Adequate birth control measures should be taken during study treatment and thecorresponding washout period.

Exclusion

Exclusion Criteria:

  1. Received any of the following interventions:
  • Prior therapy for PTCL prior to enrollment, except short-term corticosteroids (duration ≤ 7 days, equivalent prednisone dose ≤ 15 mg/day).
  • Prior radiation therapy for PTCL except local therapy for individual areas.
  • Currently receiving other systemic antineoplastic or investigational therapy.
  • Participants who have received more than 200 mg/m2 doxorubicin or otherequivalent doses of anthracycline/anthraquinone (e.g., epirubicin, daunorubicin,mitoxantrone, etc.) cumulatively.
  • Major surgical procedures (excluding routine lymphoma care programs such asvascular access placement, biopsy, etc.) or significant trauma within 4 weeksprior to the first dose of study treatment, or anticipation of the need for majorsurgery during the study.
  • Prior treatment with JAK or STAT3 inhibitors following diagnosis of PTCL.
  • Live vaccine within 28 days prior to enrollment.
  • Participants currently receiving (or unable to discontinue for at least 1 weekprior to first dose) vitamin K antagonists, antiplatelets, or anticoagulants.
  • Participants currently receiving (or unable to discontinue for at least 1 weekprior to receiving the first dose) medications or herbal supplements known to behighly potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP orP-gp with a narrow therapeutic index (see Section 6.8).
  1. Participants with clinical manifestations or imaging findings suggesting centralnervous system or leptomeningeal lymphoma.
  2. Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lungdisease, radiation pneumonitis requiring steroid therapy, or any prior history ofclinically active interstitial lung disease.
  3. Participants with a condition that requires treatment with immunosuppressants,biologics, or nonsteroidal anti-inflammatory drugs (NSAIDs).
  4. Participants with active infections
  5. Participants with significant cardiac disorder
  6. Other malignancies within 3 years before enrollment. However, malignancies, such asuterine and cervical carcinoma in situ, basal or squamous cell carcinoma, andnon-melanotic skin cancer, which have been clinically cured after evaluation, may beconsidered for inclusion after evaluation.
  7. Refractory nausea or vomiting that cannot be controlled by supportive therapy, chronicgastrointestinal disease, inability to swallow pharmaceutical agents or previous majorbowel resection may affect the adequate absorption of golidocitinib.
  8. Female participants who are lactating.
  9. Participants with a history of hypersensitivity against the active ingredients orexcipients of golidocitinib or against similar chemical structures or drugs of thesame class. Contraindication to any agent in the CHOP chemotherapy regimen.
  10. Participants with any severe or poorly controlled systemic disease, such as poorlycontrolled hypertension or active bleeding constitution, as judged by the investigatoror other evidence.
  11. Participants with an intercurrent illness that, in the opinion of the investigator,may jeopardize compliance with the protocol, including any significant medicalcondition, laboratory abnormality, or psychiatric disorder.
  12. Participants with psychological, familial, social, or geographical conditions thatpreclude compliance with the program. Any condition that would confound the ability tointerpret study data.
  13. Participating in study planning and implementation.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: CHOP Regimen
Phase: 2
Study Start date:
August 03, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.