Go-CHOP as the Frontline Therapy for PTCL

NCT05963347 | Recruiting Phase 2

• 1 other identifier: DZ2022J0003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  TEAE, lab test

  From first dose till 28 days post the last dose

Secondary Outcomes (4)

• Complete Response Rate

  From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)

• Objective Response Rate

  From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)

• Progression Free Survival

  From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)

• Duration of Response

  from first documented response till disease progression or death of any reason (up to 2 years)

Study Arms (1)

Go-CHOP

EXPERIMENTAL

Golidocitinib in combination with CHOP

Drug: Golidocitinib; Drug: CHOP Regimen

Interventions

Golidocitinib DRUG

Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib.

Also known as: AZD4205, DZD4205

Go-CHOP

CHOP Regimen DRUG

CHOP will be administered in a 21-day cycle for a maximum of 6 cycles.

Also known as: Cyclophosphamide, doxorubicin, vincristine, prednisone

Go-CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 TFH phenotype)
• 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)

You may not qualify if:

• 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 other equivalent doses of anthracycline/anthraquinone (e.g., epirubicin, daunorubicin, mitoxantrone, etc.) cumulatively.
• Major surgical procedures (excluding routine lymphoma care programs such as vascular access placement, biopsy, etc.) or significant trauma within 4 weeks prior to the first dose of study treatment, or anticipation of the need for major surgery 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 week prior to first dose) vitamin K antagonists, antiplatelets, or anticoagulants.
• Participants currently receiving (or unable to discontinue for at least 1 week prior to receiving the first dose) medications or herbal supplements known to be highly potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with a narrow therapeutic index (see Section 6.8).
• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

VAP-cyclo protocol; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Keshu Zhou, Dr.

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keshu Zhou, Dr.

CONTACT

+86 (0371) 65587513; drzhouks77@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: August 3, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)