Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneou… (NCT03011814) | Clinical Trial Compass
RecruitingPhase 1/2
Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma
United States78 participantsStarted 2017-03-08
Plain-language summary
This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Registered into Revlimid REMS program
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 1
* Relapsed/refractory disease
* Failed \>= 2 prior systemic therapies \*NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin
CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY
* Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: \>= stage IIB OR \>= stage IB-IIA folliculotropic/transformed MF; Phase 2: \>= stage IB
* Stage of disease according to TNMB classification
* Pathology report must be diagnostic or be consistent with MF/SS criteria
* SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
* For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used
* Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count
* Baseline skin biopsy taken within 6 months available for …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CTCL specific response assessed by Lugano Classification
Timeframe: Up to 12 months
2
Dose limiting toxicity assessed by CTCAE version 4.03
Timeframe: Up to 84 days
3
Duration of Complete Response
Timeframe: Date when criteria for CR first met until time of loss of CR (relapse/recurrence) or death (as a result of MF/SS or acute toxicity of treatment), assessed up to 12 months
4
Event-Free Survival
Timeframe: From date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, assessed up to 12 months
5
Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03
Timeframe: From date of first dose of study drug to date of death from any cause, assessed up to 12 months
8
Progression Free Survival (PFS)
Timeframe: Date of initiation of treatment to first date meets criteria for progressive disease or death as a result of any cause, assessed up to 12 months
9
Response duration
Timeframe: From the date of first documented response to the date of first documented disease relapse, progression or death whichever occurs first, assessed up to 12 months
10
Time to response
Timeframe: Date of initiation of treatment to date when criteria for response (PR or CR) first met, assessed up to 12 months