- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077723
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
March 26, 2024 updated by: Hoffmann-La Roche
An Open-Label, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of RO7227166 (a CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL).
RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab.
A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab.
This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
498
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: BP41072 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter MacCallum Cancer Centre
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Gent, Belgium, 9000
- Recruiting
- UZ Gent
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København Ø, Denmark, 2100
- Recruiting
- Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
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Lille, France, 59037
- Recruiting
- CHRU de Lille
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Montpellier, France, 34295
- Recruiting
- CHU Montpellier - Saint ELOI
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Pierre Benite, France, 69495
- Recruiting
- Centre Hospitalier Lyon Sud
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Rennes, France, 35033
- Recruiting
- CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte
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Lombardia
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Bergamo, Lombardia, Italy, 24127
- Recruiting
- ASST PAPA GIOVANNI XXIII; Ematologia
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Rozzano, Lombardia, Italy, 20089
- Recruiting
- Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron; Servicio de Hematologia
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Leicester, United Kingdom, LE1 5WW
- Active, not recruiting
- The HOPE Clinical Trials Unit
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London, United Kingdom, W1T 7HA
- Active, not recruiting
- University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
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California
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Pasadena, California, United States, 91105
- Active, not recruiting
- City of Hope Medical Center; Hematology
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San Francisco, California, United States, 94158
- Recruiting
- University of California San Francisco
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Colorado
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Denver, Colorado, United States, 80218
- Recruiting
- Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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Texas
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Houston, Texas, United States, 77030-4009
- Recruiting
- The University of Texas MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Depending upon study part: a history or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least two prior treatment regimens; and no available treatment options that are expected to prolong survival
- Must have at least one measureable target lesion (>/= 1.5 cm) in its largest dimension by computed tomography scan
- Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator's determination, providing the participant has more than one measurable target lesion
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of >/= 12 weeks
- Adverse events from prior anti-cancer therapy must have resolved to Grade </= 1
- Adequate liver, haematological, and renal function
- Negative test results for acute or chronic hepatitis B virus infection
- Negative test results for hepatitis C virus and HIV
- The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing drug exposure
- Female participants: A female participant is eligible to participate if she is not pregnant and not breastfeeding, and if at least one of the following applies: women of non-childbearing potential (WONCBP); women of child bearing potential (WOCBP) who agree to remain abstinent or use two highly effective contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 18 months after obinutuzumab or 3.5 months after the last dose of RO7227166, 2 months after last dose of glofitamab, or 3 months after the last dose of tocilizumab, whichever is longer. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal occlusion/ ligation, male sexual partner who is sterilized, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method; have a negative pregnancy test (blood) within the 7 days prior to the first study treatment administration
- Male participants: During the treatment period and for at least 3 months after obinutuzumab, or 3.5 months after the last dose of RO7227166, 2 months after the last dose of glofitamab, or 2 months after the last dose of tocilizumab whichever is longer, agreement to: Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year, with a partner who is a women of childbearing potential. With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo; refrain from donating sperm during this same period
Exclusion Criteria:
- Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count or the presence of abnormal cells in the peripheral blood differential signifying circulating lymphoma cells
- Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
- Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics
- Pregnant or breast-feeding or intending to become pregnant during the study
- Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines or monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on D-7
- History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents and auto-immune disease
- Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to obinutuzumab infusion
- Prior solid organ transplantation
- Prior allogeneic stem cell transplant (SCT) and prior chimeric antigen receptor -T-cell therapy
- Autologous SCT within 100 days prior to obinutuzumab infusion
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy and confirmed progressive multifocal leukoencephalopathy
- Current or past history of central nervous system (CNS) lymphoma and CNS disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
- Major surgery or significant traumatic injury < 28 days prior to the Gpt infusion or anticipation of the need for major surgery during study treatment
- Participants with another invasive malignancy in the last 2 years
- Significant cardiovascular disease
- Administration of a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study
- Received systemic immunosuppressive medications (including but not limited to cyclohosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to Gpt, with the exception of corticosteroid treatment <=25 mg/day of prednisone or equivalent, however there must be documentation that the participant was on a stable dose of at least a 2-week duration prior to Gpt infusion. Inhaled and topical steriods are permitted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part I
Combination Dose-Escalation: Mixed r/r NHL participants will receive a fixed dose of obinutuzumab seven days prior to first administration of RO7227166.
RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab in a three-weekly schedule (Q3W).
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RO7227166 will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Other Names:
A fixed dose of obinutuzumab will be administered seven days prior to first does of RO7227166 and glofitamab and then Q3W in combination with RO7227166 in Part I
Other Names:
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Other Names:
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Experimental: Part II
Combination Dose-Escalation: Mixed r/r participants and participants with mixed r/r mantle cell lymphoma (MCL) and Richters transformation will receive a fixed dose of obinutuzumab seven days prior to first administration of RO7227166.
RO7227166 will be administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
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RO7227166 will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Other Names:
A fixed dose of obinutuzumab will be administered seven days prior to first does of RO7227166 and glofitamab and then Q3W in combination with RO7227166 in Part I
Other Names:
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Other Names:
A fixed dose of glofitamab will be administered Q3W in combination with RO7227166 in Part II and Part III
Other Names:
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Experimental: Part III
Dose-Expansion Stage: Participants with r/r follicular lymphoma (FL), r/r diffuse large B-cell lymphoma (DLBCL), and r/r MCL will receive RO7227166 administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
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RO7227166 will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
Other Names:
A fixed dose of obinutuzumab will be administered seven days prior to first does of RO7227166 and glofitamab and then Q3W in combination with RO7227166 in Part I
Other Names:
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
Other Names:
A fixed dose of glofitamab will be administered Q3W in combination with RO7227166 in Part II and Part III
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Nature and frequency of dose-limiting toxicities (DLTs)
Time Frame: 28 days in Part I and Part II
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28 days in Part I and Part II
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Proportion of Participants with Adverse Event (AE)
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Incidence, nature, and severity of AEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Overall Response Rate (ORR)
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Disease Control Rate (DCR)
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Duration of Response (DOR)
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Progression-free Survival (PFS)
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Overall Survival (OS)
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Complete Response (CR)
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Total exposure (area under the concentration time curve [AUC]) of RO7227166 in combination with obinutuzumab and glofitamab
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Maximum serum concentration (peak concentration, Cmax) of RO7227166 in combination with obinutuzumab and glofitamab
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Minimum serum concentration (trough concentration, Cmin) of RO7227166 in combination with obinutuzumab and glofitamab
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Clearance (CL) of RO7227166 in combination with obinutuzumab and glofitamab
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Volume of distribution of steady state (Vss) and half-life (t1/2) of RO7227166 in combination with obinutuzumab and glofitamab
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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ORR
Time Frame: Part I: Up to 24 months; Part II/III Up to 18 months
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Part I: Up to 24 months; Part II/III Up to 18 months
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DCR
Time Frame: Part I: Up to 24 months; Part II/III Up to 18 months
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Part I: Up to 24 months; Part II/III Up to 18 months
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DOR
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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PFS
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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OS
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Proportion of Participants with Adverse Event (AE)
Time Frame: After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5.0
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After end of Study approximately every 3 months until death, loss to follow-up or study termination
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Total exposure (area under the concentration time curve [AUC]) of RO7227166 in combination with glofitamab
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Maximum serum concentration (peak concentration, Cmax) of RO7227166 in combination with glofitamab
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Minimum serum concentration (trough concentration, Cmin) of RO7227166 in combination with glofitamab
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Clearance (CL) of RO7227166 in combination with glofitamab
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Volume of distribution of steady state (Vss) and half-life (t1/2) of RO7227166 in combination with glofitamab Part I/II/III
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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T-cell and Natural killer (NK)-cell status in blood, using markers of T and NK-cell lineage, function and activation including, but not limited to, CD3, CD8, 41BB, and Ki67 expression
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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B-cell reduction in blood and tumor tissue
Time Frame: Part I: Up to 24 months; Part II/III: Up to 18 months
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Part I: Up to 24 months; Part II/III: Up to 18 months
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Change from Baseline in RO7227166 Anti-Drug Antibody (ADA) Titer
Time Frame: Part 1: Up to 24 months; Part ll/lll: Up to 18 months
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Part 1: Up to 24 months; Part ll/lll: Up to 18 months
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Time to First Complete Response (TFCR)
Time Frame: Up to 18 months
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Up to 18 months
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Time to First Overall Response (TFOR)
Time Frame: Up to 18 months
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Up to 18 months
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Duration of Complete Response (DOCR)
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Change from Baseline in Physical Function, Role Function, and Health-Related Quality of Life (HRQoL) Based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Change from Baseline in Physical Function, Role Function, and HRQoL According to the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Scale
Time Frame: Part III: Up to 18 months
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Part III: Up to 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2019
Primary Completion (Estimated)
March 31, 2025
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
September 3, 2019
First Posted (Actual)
September 4, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP41072
- 2019-000416-28 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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