Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

Phase 2

Not yet recruiting

• Conditions: Enteropathy Associated T Cell Lymphoma
• Interventions: Drug: Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone); Drug: Golidocitinib

• Registration Number: NCT06701344
• Lead Sponsor: Ruijin Hospital

Brief Summary

The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-04
• Primary Completion: 2026-05-04
• Study Completion: 2027-12-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Age: 18-75 years old, both male and female participants are eligible; Histopathologically confirmed, untreated intestinal T-cell lymphoma, including: enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, intestinal T-cell lymphoma not otherwise specified (NOS), and other subtypes of intestinal T-cell lymphoma deemed appropriate for inclusion by the investigator; Expected survival of ≥12 weeks, with cardiac, pulmonary, hepatic, and renal functions assessed by the investigator as adequate for the proposed treatment regimen; Female participants of childbearing potential and male participants with partners of childbearing potential must agree to and adhere to effective contraceptive measures during the treatment period and for 180 days after the last dose of the study drug; Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up assessments.

Exclusion Criteria

Involvement of the central nervous system (CNS); Receipt of any antitumor treatment (including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or investigational drugs) within 28 days prior to the first dose or within five half-lives of the antitumor drug, whichever is shorter; Major surgery within 28 days prior to the first dose or planned surgery during the study period; Presence of other uncontrolled malignancies. Early-stage cancers that have been treated with curative intent, such as in situ lung cancer, non-melanoma skin cancers (basal or squamous cell carcinoma), or cervical carcinoma in situ, may be excluded at the investigator's discretion; History of allogeneic hematopoietic stem cell transplantation;

Any of the following treatment histories:

1. Current use (or inability to discontinue use) of strong CYP3A inducers (within at least 3 weeks) or strong inhibitors (within at least 1 week) prior to the first dose;
2. Prior use of JAK or STAT3 inhibitors;
3. Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue these medications within 1 week prior to the first dose);
4. Vaccination with live vaccines within 28 days prior to the first dose (except for attenuated influenza vaccines);

Active infections, including:

1. Known active or latent tuberculosis, including positive tuberculin skin tests (PPD), or findings of active or latent tuberculosis on chest X-ray/CT scans (positive skin test defined as an induration diameter >10 mm or according to local clinical standards);
2. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS);
3. Active chronic hepatitis B or hepatitis C infections, defined as hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positivity. Patients with HBsAg-negative but hepatitis B core antibody (HBcAb)-positive results must undergo hepatitis B virus DNA testing, and those with HBV DNA ≥1000 IU/mL will be excluded;
4. Active infections requiring treatment within 14 days, including pneumonia;

Poorly controlled cardiac symptoms or diseases, such as:

1. NYHA class > II heart failure;
2. Unstable angina;
3. Myocardial infarction within 1 year;
4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
5. Left ventricular ejection fraction (LVEF) ≤ 50%;

Abnormal laboratory test results during screening (unless attributed to lymphoma):

Neutrophils <1.5×10⁹/L; Platelets <75×10⁹/L; ALT or AST >2× upper limit of normal (ULN), alkaline phosphatase (AKP), or bilirubin >1.5× ULN; Creatinine >1.5× ULN; History of interstitial lung disease, excluding asymptomatic, radiation-induced interstitial lung disease; Unresolved drug-related adverse events ≥ grade 2 (CTCAE) prior to the first dose, except for alopecia; Hypersensitivity to golisitinib, capsule excipients, or chemically related compounds; Pregnancy, lactation, or unwillingness to use contraception for female participants of childbearing potential; Known history of substance or drug abuse; Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase study participation risk, interfere with study outcomes, or, in the investigator's opinion, make the patient unsuitable for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Go-CHOP	Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)	Golidocitinib 150mg qd plus Standard CHOP regimen
Go-CHOP	Golidocitinib	Golidocitinib 150mg qd plus Standard CHOP regimen

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	At the end of Cycle 6 (each cycle is 21days)	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Baseline up to data cut-off(up to approximately 3 years)	Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Objective Response Rate	At the end of Cycle 6 (each cycle is 21days)	Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Duration of Response	Baseline up to data cut-off(up to approximately 3 years)	Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Overall survival	Baseline up to data cut-off(up to approximately 3 years)	Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Adverse Events	Baseline up to data cut-off(up to approximately 3 years)	Adverse Events are assessed based on CTCAE v5.0