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Go-CHOP as the Frontline Therapy for PTCL

Primary Purpose

Peripheral T Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Golidocitinib
CHOP Regimen
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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) 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: 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 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.

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Go-CHOP

Arm Description

Golidocitinib in combination with CHOP

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE, lab test

Secondary Outcome Measures

Complete Response Rate
Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria
Objective Response Rate
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Progression Free Survival
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Duration of Response
Duration of response assessed by investigator per Lugano 2014 criteria

Full Information

First Posted
July 10, 2023
Last Updated
August 29, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05963347
Brief Title
Go-CHOP as the Frontline Therapy for PTCL
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Go-CHOP
Arm Type
Experimental
Arm Description
Golidocitinib in combination with CHOP
Intervention Type
Drug
Intervention Name(s)
Golidocitinib
Other Intervention Name(s)
AZD4205, DZD4205
Intervention Description
Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib.
Intervention Type
Drug
Intervention Name(s)
CHOP Regimen
Other Intervention Name(s)
Cyclophosphamide, doxorubicin, vincristine, prednisone
Intervention Description
CHOP will be administered in a 21-day cycle for a maximum of 6 cycles.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
TEAE, lab test
Time Frame
From first dose till 28 days post the last dose
Secondary Outcome Measure Information:
Title
Complete Response Rate
Description
Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria
Time Frame
From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Title
Objective Response Rate
Description
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Time Frame
From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Title
Progression Free Survival
Description
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Time Frame
From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)
Title
Duration of Response
Description
Duration of response assessed by investigator per Lugano 2014 criteria
Time Frame
from first documented response till disease progression or death of any reason (up to 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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) 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: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keshu Zhou, Dr.
Phone
+86 (0371) 65587513
Email
drzhouks77@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou, Dr.
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou, Dr.
Phone
+86 (0371) 65587513
Email
drzhouks77@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Go-CHOP as the Frontline Therapy for PTCL

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