Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients (GOAL)

November 21, 2024 updated by: Zhao Weili, Ruijin Hospital

A Prospective, Multicenter, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of the Combination Therapy of Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Go-CHOP
Golidocitinib 150mg qd plus Standard CHOP regimen
Drug: Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)

Induction Treatment:

Golidocitinib:150mg QD Cyclophosphamide:750mg/m2，d1 vincristine:1.4mg/m2，d1(max 2mg) doxorubicin:50mg/m2，d1 Prednisone:60mg/m2 (max 100mg)，d1-d5 Every 21 days

Drug: Golidocitinib

Maintenance Treatment:

Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: 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.
At the end of Cycle 6 (each cycle is 21days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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.
Baseline up to data cut-off(up to approximately 3 years)
Objective Response Rate
Time Frame: 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.
At the end of Cycle 6 (each cycle is 21days)
Duration of Response
Time Frame: 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.
Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Time Frame: 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.
Baseline up to data cut-off(up to approximately 3 years)
Adverse Events
Time Frame: Baseline up to data cut-off(up to approximately 3 years)
Adverse Events are assessed based on CTCAE v5.0
Baseline up to data cut-off(up to approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 4, 2024

Primary Completion (Estimated)

May 4, 2026

Study Completion (Estimated)

December 4, 2027

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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