Is NCT03011814 recruiting in Philadelphia, PA?

Yes, NCT03011814 is currently recruiting participants at its Philadelphia, PA location. This folliculotropic mycosis fungoides clinical trial is actively enrolling qualified participants.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Folliculotropic Mycosis Fungoides Clinical Trial in Philadelphia, PA

Q: How do I join the folliculotropic mycosis fungoides clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Folliculotropic Mycosis Fungoides Study in Philadelphia

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.

Sponsor: City of Hope Medical Center

Who Can Participate

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 central review submission PERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY

Histologically confirmed PTCL as defined by World Health Organization (WHO) 2008 criteria

Measurable and/or evaluable disease per Lugano Classification

Absolute neutrophil count (ANC) \>= 1000/mm\^3 \

Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement

Platelets \>= 100,000/mm\^3 \

Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement

Total serum bilirubin =\< 2.2 mg/dL

Aspartate aminotransferase (AST) =\< 2 x upper limit of normal (ULN)

Alanine aminotransferase (ALT) =\< 2 x ULN

Creatinine clearance of \>= 60 mL/min per the Cockcroft-Gault formula

If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =\< 1.5 x ULN \

If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants

Female of childbearing potential: negative urine or serum pregnancy test \

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Female of child bearing potential: willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication \

Childbearing potential defined as not being surgically sterilized or have not been free from menses for \> 1 year

Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria

Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines

Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs)

Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy

Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy

Any skin-directed therapy within 14 days prior to initiating protocol therapy

Any radiation therapy within 21 days prior to initiating protocol therapy

Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion:

Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days

Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent

Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy

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

Disease free of prior malignancies for \>= 5 years with the exception of:

Currently treated squamous cell and basal cell carcinoma of the skin

Carcinoma in situ of the cervix, or

Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or

Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or

Any other malignancy that has/have been curatively treated with surgery and/or localized radiation

Allergic reaction/ hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab

Female only: pregnant or lactating

Prior stem cell transplantation

Acute infection requiring systemic treatment

Known history of human immunodeficiency virus (HIV) infection

Active hepatitis B or C infection

Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy

Current peripheral neuropathy \>= grade 2

Renal failure requiring hemodialysis or peritoneal dialysis

Unstable cardiac disease as defined by one of the following:

Cardiac events such as myocardial infarction (MI) within the past 6 months

NYHA (New York Heart Association) heart failure class III-IV

Uncontrolled atrial fibrillation or hypertension

Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment

Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:

Vitiligo or alopecia;

Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or

Psoriasis not requiring systemic treatment

History of primary immunodeficiency

Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc

In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT03011814) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Folliculotropic Mycosis Fungoides Treatment Options in Philadelphia, PA

If you're searching for folliculotropic mycosis fungoides treatment options in Philadelphia, PA, this clinical trial (NCT03011814) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced folliculotropic mycosis fungoides specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all folliculotropic mycosis fungoides clinical trials near you to find additional studies recruiting in your area.

Folliculotropic Mycosis Fungoides Clinical Trial in Philadelphia, PA

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