Phase
Condition
Lymphoma
Lymphoproliferative Disorders
Non-hodgkin's Lymphoma
Treatment
Biospecimen Collection
Cemiplimab
Biopsy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >= 18 years
Relapsed or refractory:
Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the followinghistologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 times upperlimit of normal (ULN) (obtained =< 15 days prior to registration)
Creatinine =< 2.0 mg/dL (obtained =< 15 days prior to registration)
Direct bilirubin =< 1.5 x ULN (obtained =< 15 days prior to registration)
International normalized ratio (INR)/prothrombin time (PT) and activated partialthromboplastin time (aPTT) =< 1.5 x ULN (obtained =< 15 days prior to registration)
If baseline liver disease, Child Pugh score not exceeding class A (obtained =< 15days prior to registration)
Negative pregnancy test for persons of child-bearing potential (obtained =< 15 daysprior to registration)
FOR T-Cell Lymphoma (TCL)/B-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) >= 1,000/microliter (μL) (obtained =< 14 days prior to registration)
FOR TCL/BCL ONLY: Platelets >= 100,000/μL (obtained =< 14 days prior toregistration)
FOR TCL/BCL ONLY: Hemoglobin >= 8.5 g/dl (obtained =< 14 days prior to registration)
FOR TCL/BCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): musthave at least one lesion that has a single diameter of > 2 cm or tumor cells in theblood > 5 x 10^9/L; NOTE: skin lesions can be used if the area is > 2 cm in at leastone diameter and photographed with a ruler and the images are available in themedical record
Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollmentlumbar puncture not mandatory
Ability to provide written informed consent
Willingness to return to Mayo Clinic for follow-up
Life expectancy >= 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Willing to provide mandatory biological specimens for research purposes
Exclusion
Exclusion Criteria:
Availability of and patient acceptance of curative therapy
Uncontrolled infection
Active tuberculosis or hepatitis, or chronic hepatitis
Any of the following prior therapies:
Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =< 2 weeks priorto registration
Immunotherapy (monoclonal antibodies) =< 4 weeks prior to registration
Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4half-lives of the last dose of the agent
New York Heart Association classification III or IV, known symptomatic coronaryartery disease, or symptoms of coronary artery disease on systems review, or knowncardiac arrhythmias [atrial fibrillation or supraventricular tachycardia (SVT)]
Active CNS disorder or seizure disorder or known CNS disease or neurologicsymptomatology; in case of AML active CNS involvement as detected by lumbar punctureor neuro-imaging (only to be done if clinically indicated)
Human immunodeficiency virus (HIV) positive test result or other immunodeficiency orimmunosuppression
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapyconsidered investigational (used for a non-Food and Drug Administration [FDA]approved indication and in the context of a research investigation);
NOTE: in TCL, patients may use topical emollients or corticosteroids, aceticacid soaks, etc. to control pruritis and prevent infection; no topicalchemotherapy is allowed (no topical nitrogen mustard)
Any of the following because this study involves an investigational agent whosegenotoxic, mutagenic and teratogenic effects on the developing fetus and newborn areunknown:
Pregnant women or women of reproductive ability who are unwilling to useeffective contraception
Nursing women
Men who are unwilling to use a condom (even if they have undergone a priorvasectomy) while having intercourse with any woman, while taking the drug andfor 4 weeks after stopping treatment
ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH IPILIMUMAB ANDCEMIPLIMAB) ONLY:
Diagnosis of AML
Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)
Hypersensitivity to ipilimumab or its excipients
Study Design
Study Description
Connect with a study center
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United StatesActive - Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
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