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Monoclonal Antibodies

Durvalumab +/− Lenalidomide for T-Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Christiane Querfeld, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1

Female of childbearing potential: negative urine or serum pregnancy test

Must not have

Acute infection requiring systemic treatment

History of pneumonitis (non-infectious) that required steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing durvalumab with or without lenalidomide to treat patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment.

Who is the study for?

This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.

What is being tested?

The trial is testing the effectiveness of durvalumab alone versus in combination with lenalidomide in treating T cell lymphoma that has returned after treatment. Durvalumab is a monoclonal antibody that may block cancer growth by targeting specific cells, while lenalidomide can stop cancer cells from growing by various mechanisms.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation of organs; infusion reactions; blood disorders; increased risk of infection; fatigue; allergic reactions to components of the drugs being tested; skin rash and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from side effects of previous treatments, except for hair loss.

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I am a woman who can have children and my pregnancy test is negative.

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I am able to get out of my bed or chair and move around.

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My blood clotting tests are within normal limits.

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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

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My condition has returned or didn't respond to treatment.

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My lymphoma is confirmed as PTCL by WHO standards.

Exclusion Criteria

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

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I am currently being treated for a serious infection.

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I have or had lung inflammation treated with steroids.

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I have not received a live vaccine in the last 30 days.

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I have not received immunotherapy such as checkpoint inhibitors, cell therapies, or cancer vaccines.

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I am not pregnant or breastfeeding.

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I am allergic to thalidomide or durvalumab ingredients.

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I do not have unstable heart conditions.

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I have not taken Lenalidomide, Thalidomide, or similar drugs.

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I haven't had any systemic therapy or monoclonal antibody treatment in the last 28 days or 5 half-lives, whichever is shorter.

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I require dialysis for kidney failure.

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I have had a stem cell transplant before.

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I need ongoing steroid or immune system treatments and may need more during the trial.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I haven't taken any monoclonal antibody treatment recently.

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I haven't taken immunosuppressive medication in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

CTCL specific response assessed by Lugano Classification

Dose limiting toxicity assessed by CTCAE version 4.03

Duration of Complete Response

+6 more

Secondary study objectives

Clinically Meaningful Reduction in Pruritus (CMRP)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (durvalumab, lenalidomide)Experimental Treatment3 Interventions

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab)Experimental Treatment2 Interventions

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Lenalidomide

2005

Completed Phase 3

~2240