Study on Durvalumab With or Without Lenalidomide for Treating Relapsed or Resistant T Cell Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT03011814
This clinical trial is exploring the effectiveness and safety of using durvalumab, with or without lenalidomide, to treat patients with T cell lymphoma that has returned or is not responding to treatment. The study aims to find the best dose and understand the side effects of these treatments.
Patient Parameters
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Program Overview
This study is testing how well the drug durvalumab works alone or in combination with lenalidomide for treating patients with cutaneous or peripheral T cell lymphoma that has come back or is not responding to treatment. Durvalumab is a type of monoclonal antibody that may help stop cancer cells from growing and spreading. Lenalidomide is a chemotherapy drug that works in different ways to stop cancer cells, either by killing them, stopping them from dividing, or preventing them from spreading. The study will help determine if using these drugs together is more effective than using durvalumab alone.
Description
The study has two main parts: Phase I and Phase II.
In Phase I, researchers will determine the safest dose of lenalidomide when given with a fixed dose of durvalumab. They will also assess the safety and side effects of this combination.
In Phase II, the study will evaluate how well durvalumab works alone and in combination with lenalidomide by measuring the overall response rate, which indicates how many patients experience tumor shrinkage.
Secondary goals include estimating how long patients respond to treatment and their survival rates, as well as assessing any reduction in itching for patients with cutaneous T-cell lymphoma (CTCL).
The study will also explore the characteristics of cancer cells in the skin and their interaction with other immune cells, as well as identify specific genetic markers that may predict treatment response or side effects.
Participants will be randomly assigned to one of two groups:
- Group 1: Receives durvalumab intravenously every 28 days for up to 13 cycles, unless the disease progresses or side effects become unacceptable.
- Group 2: Receives durvalumab intravenously and lenalidomide orally for 21 days in each 28-day cycle, for up to 13 cycles, unless the disease progresses or side effects become unacceptable.
After completing the treatment, patients will be monitored for up to 12 months.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Must be registered in the Revlimid REMS program.
- Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Must have recovered from previous treatment side effects to a mild level.
- Must have relapsed or resistant disease after at least two prior treatments.
- For cutaneous T-cell lymphoma (CTCL):
- Must have a confirmed diagnosis of mycosis fungoides or Sezary syndrome.
- Must have measurable disease based on specific assessment tools.
- Must provide a recent skin biopsy for review.
- For peripheral T-cell lymphoma (PTCL):
- Must have a confirmed diagnosis based on specific criteria.
- Must have measurable disease based on standard criteria.
- Must have adequate blood cell counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control or abstain from heterosexual activity during the study and for 90 days after the last dose.
- Men must agree to use contraception during the study and for 90 days after the last dose.
Exclusion Criteria
- Previous treatment with certain immunotherapies or cancer vaccines.
- Recent treatment with lenalidomide, thalidomide, or similar drugs.
- Recent treatment with monoclonal antibodies or other systemic therapies.
- Recent skin-directed therapy or radiation therapy.
- Use of immunosuppressive medication, except for certain low-dose steroids.
- Recent live vaccine.
- History of non-infectious pneumonitis requiring steroids.
- Recent or active other cancers, except for certain skin or cervical cancers.
- Allergic reactions to thalidomide or durvalumab components.
- Pregnant or breastfeeding women.
- Previous stem cell transplantation.
- Active infection requiring treatment.
- Known HIV or active hepatitis B or C infection.
- Conditions requiring chronic steroid or immunosuppressive treatment.
- Current severe nerve damage or kidney failure requiring dialysis.
- Unstable heart disease or recent major surgery.
- Active autoimmune or inflammatory disorders requiring treatment.
- History of primary immunodeficiency.
- Gastrointestinal disease affecting drug absorption.
- Any other condition that may interfere with study participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| Thomas Jefferson University Hospital | 19107 | Philadelphia | Pennsylvania |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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