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

NCT06701344 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: GOAL
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Enteropathy Associated T Cell Lymphoma

Keywords

Enteropathy-Associated T-Cell Lymphoma; Golidocitinib

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  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 Outcomes (5)

• Progression-free survival

  Baseline up to data cut-off(up to approximately 3 years)

• Objective Response Rate

  At the end of Cycle 6 (each cycle is 21days)

• Duration of Response

  Baseline up to data cut-off(up to approximately 3 years)

• Overall survival

  Baseline up to data cut-off(up to approximately 3 years)

• Adverse Events

  Baseline up to data cut-off(up to approximately 3 years)

Study Arms (1)

Go-CHOP

EXPERIMENTAL

Golidocitinib 150mg qd plus Standard CHOP regimen

Drug: Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone); Drug: Golidocitinib

Interventions

Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone) DRUG

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

Go-CHOP

Golidocitinib DRUG

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.

Go-CHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• 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;
• Prior use of JAK or STAT3 inhibitors;
• Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue these medications within 1 week prior to the first dose);
• Vaccination with live vaccines within 28 days prior to the first dose (except for attenuated influenza vaccines);
• Active infections, including:
• 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);
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS);
• 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;
• Active infections requiring treatment within 14 days, including pneumonia;
• Poorly controlled cardiac symptoms or diseases, such as:
• NYHA class \> II heart failure;
• Unstable angina;
• Myocardial infarction within 1 year;

Sponsors & Collaborators

• Ruijin Hospital: lead

Related Publications (12)

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• d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Osterborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Ostenstad B, Fagerli UM, Gadeberg OV, Sundstrom C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. doi: 10.1200/JCO.2011.40.2719. Epub 2012 Jul 30.

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  PMID: 23313469 BACKGROUND

• Sharaiha RZ, Lebwohl B, Reimers L, Bhagat G, Green PH, Neugut AI. Increasing incidence of enteropathy-associated T-cell lymphoma in the United States, 1973-2008. Cancer. 2012 Aug 1;118(15):3786-92. doi: 10.1002/cncr.26700. Epub 2011 Dec 13.

  PMID: 22169928 BACKGROUND

• West J, Jepsen P, Card TR, Crooks CJ, Bishton M. Incidence and Survival in Patients With Enteropathy-associated T-Cell Lymphoma: Nationwide Registry Studies From England and Denmark. Gastroenterology. 2023 Oct;165(4):1064-1066.e3. doi: 10.1053/j.gastro.2023.06.003. Epub 2023 Jun 9. No abstract available.

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• Verbeek WH, Van De Water JM, Al-Toma A, Oudejans JJ, Mulder CJ, Coupe VM. Incidence of enteropathy--associated T-cell lymphoma: a nation-wide study of a population-based registry in The Netherlands. Scand J Gastroenterol. 2008;43(11):1322-8. doi: 10.1080/00365520802240222.

  PMID: 18618372 BACKGROUND

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  PMID: 21566094 BACKGROUND

MeSH Terms

Conditions

Enteropathy-Associated T-Cell Lymphoma

Interventions

Cyclophosphamide; Vincristine; Doxorubicin; 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; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Li Wang

CONTACT

+86 02164370045; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director，Shanghai Institute of Hematology

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 22, 2024
• Study Start: December 4, 2024
• Primary Completion: May 4, 2026
• Study Completion (Estimated): December 4, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share