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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Go-CHOP | Experimental | Golidocitinib in combination with CHOP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golidocitinib | Drug | Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | TEAE, lab test | From first dose till 28 days post the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria | From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks) |
| Objective Response Rate |
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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 the informed consent form.
The participant has an ECOG performance status of 0 to 2 and has not deteriorated in the past 2 weeks.
Life expectancy ≥ 3 months.
Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma therapy; and assessed by a local pathologist according to the 2016 revised World Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as the following subtypes:
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 the corresponding washout period.
Exclusion Criteria:
Received any of the following interventions:
Participants with clinical manifestations or imaging findings suggesting central nervous system or leptomeningeal lymphoma.
Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any prior history of clinically 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 as uterine and cervical carcinoma in situ, basal or squamous cell carcinoma, and non-melanotic skin cancer, which have been clinically cured after evaluation, may be considered for inclusion after evaluation.
Refractory nausea or vomiting that cannot be controlled by supportive therapy, chronic gastrointestinal disease, inability to swallow pharmaceutical agents or previous major bowel resection may affect the adequate absorption of golidocitinib.
Female participants who are lactating.
Participants with a history of hypersensitivity against the active ingredients or excipients of golidocitinib or against similar chemical structures or drugs of the same class. Contraindication to any agent in the CHOP chemotherapy regimen.
Participants with any severe or poorly controlled systemic disease, such as poorly controlled hypertension or active bleeding constitution, as judged by the investigator or other evidence.
Participants with an intercurrent illness that, in the opinion of the investigator, may jeopardize compliance with the protocol, including any significant medical condition, laboratory abnormality, or psychiatric disorder.
Participants with psychological, familial, social, or geographical conditions that preclude compliance with the program. Any condition that would confound the ability to interpret study data.
Participating in study planning and implementation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keshu Zhou, Dr. | Contact | +86 (0371) 65587513 | drzhouks77@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Keshu Zhou, Dr. | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C036337 | VAP-cyclo protocol |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| CHOP Regimen | Drug | CHOP will be administered in a 21-day cycle for a maximum of 6 cycles. |
|
|
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
| From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks) |
| Progression Free Survival | Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria. | From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year) |
| Duration of Response | Duration of response assessed by investigator per Lugano 2014 criteria | from first documented response till disease progression or death of any reason (up to 2 years) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |