Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma

Running, not enrolling · Phase 1

Conditions studied: Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3a Follicular Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type, Refractory Grade 1 Follicular Lymphoma, Refractory Grade 2 Follicular Lymphoma, Refractory Grade 3a Follicular Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Stage IB Mycosis Fungoides AJCC v7, Stage II Mycosis Fungoides AJCC v7, Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage III Mycosis Fungoides AJCC v7, Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage IV Mycosis Fungoides AJCC v7

In brief

This phase I trial studies the side effects and best dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Key facts

Study ID

NCT02520791

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2016-09-13

Expected to finish

2026-12-24

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologic diagnosis of one of the following:
• For dose escalation:
• Confirmed diagnosis of peripheral T-cell lymphoma (PTCL) or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy; anaplastic large cell lymphoma (ALCL) and natural killer T-cell lymphoma nasal type (NKTCL) are excluded
• Advanced stage cutaneous T-cell lymphoma (CTCL), specifically CTCL NOS, small/medium T-cell lymphoma (SMTCL) and mycosis fungoides (MF) stage IB, IIA, IIB, III and IV that have relapsed after at least one specific prior therapy (e.g. interferon, photopheresis, denileukin difitox, bexarotene, etc); anaplastic cutaneous large cell lymphoma (ACLCL) and lymphomatoid papulopsis are excluded
• Follicular lymphoma grade 1, 2 or 3A that meets the following criteria:
• Relapsed or refractory to at least 2 lines of therapy AND
• Relapsed or refractory post autologous cell transplantation (HCT)
• For dose expansion/dose confirmation phase:
• Patients with confirmed diagnosis of peripheral T-cell lymphoma (PTCL) follicular type or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy
• At least 14 days from the last therapy dose or 5 half-lives (whichever is shorter), and resolution of toxicity related to the last therapy, excluding grade 2 or less peripheral neuropathy and alopecia; for radiation therapy, a minimum of 2 weeks and resolution of all acute toxicity will be required
• Patients must have at least one measurable lesion that can be accurately measured with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, or physical exam (by calipers only); (PTCL, AITL and follicular lymphoma patients will be assessed on this study using the Lugano criteria for the evaluation of lymphomas; CTCL and MF patients will be assessed using International Society for Cutaneous Lymphomas [ISCL] and European Organization for Research and Treatment of Cancer [EORTC] criteria)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than 6 months
• Leukocytes >= 3,000/mcL
• Hemoglobin >= 80 d/L (or >= 8 g/dL)
• Patients must not have received a transfusion, with packed red blood cells, within 2 weeks prior to sample being collected
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets (PLT) >= 50,000/mcL
• Absolute CD4 count > 100 cells/uL
• Total bilirubin < 1.5 upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine < 1.5 mg/dl (= 132 umol/L) or
• Creatinine clearance >= 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• In patients with bone marrow involvement the minimum requirement is as follows:
• Leukocytes >= 2000/mcL

You may not qualify if…

• Patients who are receiving any other investigational agents
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI-570 or history of anaphylaxis to any biological component
• Any history or evidence of opportunistic infection within 6 months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
• Evidence of active infection by hepatitis B and/or C; active viral infection by hepatitis B and hepatitis C could be associated with cytopenias (due to hypersplenism or due to the active virus itself), which could add further risk when a potential immunosuppressive medication is used; for patients with hepatitis B treated with anti-virals to undetectable viral load, and for patients with hepatitis C with undetectable ribonucleic acid (RNA) levels and no evidence of liver damage, enrollment may be considered and should discuss first with study's principal investigator
• History of human immunodeficiency virus (HIV) infection; the human immunodeficiency virus (HIV) depletes CD4 T-cells and could also have a role in T-cell anergy; since MEDI-570 preferentially affects CD4 T-cell numbers and function, and the resultant immunosuppression by this agent can be prolonged, exposing HIV patients to MEDI-570 will place them in an unnecessary risk of developing infections due to an underlying acquired cellular immunity defect
• History of primary immunodeficiency
• Receipt of live or live attenuated vaccine within 12 weeks prior to enrollment
• All potential patients must undergo a tuberculosis (TB) test prior to study entry to rule out active or latent tuberculosis (either purified protein derivative [PPD] or QuantiFERON-TB Gold, whichever is preferred and available at the institution); patients with a history of TB (even if treated), or evidence of active or latent TB, are excluded; the diagnosis of active TB is defined per current guidelines; patients with a positive TB test (e.g. PPD or QuantiFERON-TB Gold) will be excluded; patients with history of Bacille-Calmette-Guerin (BCG) vaccination will be tested with QuantiFERON-TB Gold test in order to rule out exposure to TB
• Patients who have undergone allogeneic stem cell transplantation
• Patients who have undergone autologous stem cell transplantation within 3 months from study entry
• Major surgery within 30 days prior or during the study period
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study due to the potential toxicity in pre-clinical reproductive studies; in addition, there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MEDI-570; breastfeeding should be discontinued if the mother is treated with MEDI-570
• Patients with active, known, or suspected autoimmune disease, except in these conditions:
• Participants with well-controlled asthma and/or mild allergic rhinitis (seasonal allergies) are eligible
• Participants with the following disease conditions are also eligible:
• Vitiligo,
• Type 1 diabetes mellitus
• Residual hypothyroidism due to autoimmune condition only requiring hormone replacement
• Euthyroid participants with a history of Grave's disease (participants suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug)
• For patients with ITP (idiopathic thrombocytopenic purpura) or AIHA (autoimmune hemolytic anemia), a case by case discussion with study principal investigator (PI) may be considered
• Patients not receiving systemic therapy (i.e., systemic steroids or biologic therapy with disease modifying anti-rheumatic drugs [DMARDs]) within 2 years can be also eligible
• Patients with a weight of < 39 kg

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Kansas Clinical Research Center — Fairway, Kansas, United States
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
• Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Siteman Cancer Center-South County — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• Montefiore Medical Center-Weiler Hospital — The Bronx, New York, United States
• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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