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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must sign an informed consent form prior to trial-specific procedures,sampling, and analysis.
- Participants must be at least 18 years of age (inclusive) at the time of signing theinformed consent form.
- The participant has an ECOG performance status of 0 to 2 and has not deteriorated inthe past 2 weeks.
- Life expectancy ≥ 3 months.
- 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)
- Adequate bone marrow reserve and organ system function reserve
- Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO.
- Participants should be able and willing to comply with the study protocol requirement.
- Adequate birth control measures should be taken during study treatment and thecorresponding washout period.
Exclusion
Exclusion Criteria:
- 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).
- Participants with clinical manifestations or imaging findings suggesting centralnervous system or leptomeningeal lymphoma.
- Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lungdisease, radiation pneumonitis requiring steroid therapy, or any prior history ofclinically active interstitial lung disease.
- Participants with a condition that requires treatment with immunosuppressants,biologics, or nonsteroidal anti-inflammatory drugs (NSAIDs).
- Participants with active infections
- Participants with significant cardiac disorder
- 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.
- 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.
- Female participants who are lactating.
- 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.
- Participants with any severe or poorly controlled systemic disease, such as poorlycontrolled hypertension or active bleeding constitution, as judged by the investigatoror other evidence.
- 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.
- Participants with psychological, familial, social, or geographical conditions thatpreclude compliance with the program. Any condition that would confound the ability tointerpret study data.
- 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
ChinaActive - Recruiting
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