Study of the PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Patients With Relapsed or Refractory Advanced Stage Follicular Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma

In brief

The purpose of this study is to compare the safety and effects of atezolizumab with low dose radiation on people with relapsed or refractory follicular lymphoma, In this study, the patient will get either atezolizumab with low dose radiation or, atezolizumab alone. To be better, the atezolizumab and low dose radiation should increase life by 1 year or more compared to the usual approach.

Key facts

Study ID

NCT03465891

Run by

Memorial Sloan Kettering Cancer Center

People needed

2

Starts

2018-03-09

Expected to finish

2019-12-17

Last updated by the study team

2021-01-12

Who can join

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

You may qualify if…

• Signed Informed Consent Form (ICF) Ability and willingness to comply with the requirements of the study protocol
• Age ≥ 18 years
• Relapsed or refractory follicular lymphoma grade 1, 2, or 3A
• Relapsed disease is defined as having relapsed after greater than 6 months of prior treatment for follicular lymphoma
• Refractory disease is defined as failure to achieve a complete response or relapsed within 6 months of treatment for follicular lymphoma
• Pretreatment biopsy for fresh tumor tissue collection is required
• If patient has recently undergone a biopsy and has not received any intercurrent anti-lymphoma therapy, archival tissue can be used
• Stage III/IV disease
• ° Stage II disease is also eligible if disease is not encompassible within a single radiation field, as determined by the radiation oncologist
• At least 1 prior treatment for follicular lymphoma (no restriction to number or type of prior therapies)
• Patient treated for transformed diffuse large B cell lymphoma (DLBCL) who have retrograde transformation are eligible provided they have received at least one prior treatment for the follicular lymphoma
• Site of disease amenable to low-dose, local radiotherapy (2 x 2Gy), as recommended by the radiation oncologist
• At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by CT scan or magnetic resonance imaging, as defined by the Lugano Classification
• Adequate hematologic and end organ function:
• ANC ≥ 1500 cells/µL
• If there is documented bone marrow involvement of follicular lymphoma, ANC must be >/= 1000 cells/µL
• Platelet count ≥ 75,000/µL
• If there is documented bone marrow involvement of follicular lymphoma, platelet count must be >/= 50,000/µL
• Hemoglobin ≥ 9.0 g/dL
• If there is documented bone marrow involvement of follicular lymphoma, hemoglobin must be >/= 8.0 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
• AST and ALT ≤ 3.0 x ULN
• Patients with liver involvement: AST and/or ALT ≤ 5 x ULN Alkaline phosphatase ≤ 2.5 x ULN
• Patients with documented liver involvement or bone metastases:

You may not qualify if…

• Follicular lymphoma grade 3B
• Concurrent aggressive non-Hodgkin lymphoma (e.g. diffuse large B cell lymphoma [DLBCL])
• Any anticancer therapy, including chemotherapy, hormonal therapy, investigational therapy, or radiotherapy, within 3 weeks, or 5 half lifes, whichever is shortest, prior to initiation of study treatment. However, the following are allowed:
• Hormone-replacement therapy or oral contraceptives
• Herbal therapy, provided it is discontinued at least 1 week prior to Cycle 1, Day 1
• Palliative radiotherapy for bone metastases, provided most recent fraction not given within 2 weeks of Cycle 1, Day 1 and most recent fraction was not administered to planned area of radiation while on study.
• AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 with exception of alopecia or skin/nail hyperpigmentation
• Bisphosphonate therapy for symptomatic hypercalcemia within 2 weeks of cycle 1, day 1
• ° Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed. Denosumab should not be used while on therapy
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Active central nervous system (CNS) involvement of lymphoma
• ° Patients with a history of CNS involvement of lymphoma are eligible, provided they received treatment greater than 30 days prior to cycle 1 day 1 and there is no evidence of involvement on most recent assessment
• Pregnant, or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
• ° Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
• Known hypersensitivity to Chinese hamster ovary cell products, other recombinant human antibodies, or to any component of the atezolizumab formulation
• Inability to comply with study and follow-up procedures
• Active or history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener"s granulomatosis, Sjögren"s syndrome, Bell"s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
• Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
• Patients with inactive inflammatory bowel disease, not currently receiving therapy, may be eligible.
• Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
• Rash must cover less than 10% of body surface area (BSA)
• Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
• No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Where it is running

• Memoral Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memoral Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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