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Monoclonal Antibodies

Golidocitinib for Peripheral T-Cell Lymphoma

Phase 2

Waitlist Available

Led By Luis Malpica Castillo, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed peripheral T-cell lymphoma by MD Anderson pathology review according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Eligible histological subtypes are restricted to PTCL, not otherwise specified (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), Follicular T cell lymphoma, and PTCL with T follicular helper (TFH) phenotype

Participants must be treatment naïve with no prior systemic treatment for T-cell lymphoma

Must not have

Severe or uncontrolled systemic diseases, uncontrolled hypertension, active bleeding diatheses

Active infections including known active tuberculosis (TB), known infection with human immunodeficiency virus (HIV), known active hepatitis B or hepatitis C infection, and active viral infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new drug called golidocitinib, either alone or combined with the standard drug treatment CHOP, can effectively manage a type of cancer called PTCL.

Who is the study for?

This trial is for individuals newly diagnosed with Peripheral T Cell Lymphoma (PTCL). Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have a particular stage or type of PTCL.

What is being tested?

The study is testing the effectiveness and safety of golidocitinib, alone or combined with CHOP therapy (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), in treating PTCL. It's a Phase II trial focused on understanding how well this new treatment works.

What are the potential side effects?

While specific side effects are not listed here, common ones for chemotherapy like CHOP include nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts. Golidocitinib's side effects would be detailed in the consent form.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is a specific type confirmed by a pathology review.

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I have not received any treatment for T-cell lymphoma before.

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I am 18 years old or older.

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My physical ability hasn't worsened in the last 2 weeks and I can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses, uncontrolled high blood pressure, or active bleeding disorders.

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I do not have active infections like TB, HIV, or hepatitis.

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My heart health meets the study's requirements.

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I have severe, ongoing nausea or vomiting, trouble swallowing, or have had major surgery on my intestines.

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I need treatment with immunosuppressants, biologics, or NSAIDs for my condition.

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My cancer affects the brain or its lining.

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My lung function is severely reduced.

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I am pregnant or breastfeeding and taking golidocitinib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Golidocitinib + CHOPExperimental Treatment5 Interventions

Golidocitinib will be administered at 150 mg PO daily as monotherapy unless dose modified per toxicity chart; when in combination with CHOP, the maximum dose of golidocitinib is 150 mg PO every other day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine

2003

Completed Phase 4

~2970

Cyclophosphamide

2010

Completed Phase 4

~2310