A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia (FUSION NHL 001)

A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell
• Intervention / Treatment: Drug: Lenalidomide; Drug: Durvalumab; Drug: Rituximab; Drug: Ibrutinib; Drug: Bendamustine

Detailed Description

The study was to consist of 3 parts: dose-finding, dose-confirmation, and dose-expansion. In this study, 4 treatment arms were to be investigated:

• Arm A: durvalumab and lenalidomide ± rituximab
• Arm B: durvalumab and ibrutinib
• Arm C: durvalumab and rituximab ± bendamustine
• Arm D: durvalumab (monotherapy)

The study was to start with 3 dose-finding cohorts (Arms A, B, and C) and 1 dose-confirmation cohort (Arm D) in parallel. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms. For Arms A and C, prior to enrolling participants to receive all 3 drugs, the doublet combinations were to be evaluated. Once the doublet combinations were deemed tolerable, the eventual triplet combinations were to be tested.

On 05 September 2017, the US FDA issued a Partial Clinical Hold on the study Arm A. Following this Partial Clinical Hold no more participants were enrolled into study Arm A. Participants already enrolled and treated in Arm A who were receiving clinical benefit, based on the discretion of the investigator, could continue study treatment after being reconsented. Arm B and C completed dose confirmation. The dose expansion part of the study was not opened.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Bobigny Cedex, France, 93009
    • Centre Hospitalier Universitaire d'Avicennes
  • Creteil, France, 94010
    • Hopital Henri Mondor
  • Dijon Cedex, France, 21079
    • Centre Hospitalier
  • Marseille Cedex 9, France, 13273
    • Institut Paoli Calmettes
  • Montpellier Cedex 5, France, 34295
    • Chu Montpellier
  • Montpellier Cedex 5, France, 34295
    • Local Institution - 102
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes
  • Nantes, France, 44093
    • Local Institution - 105
  • Pessac Cedex, France, 33604
    • Hôpital Haut Lévêque
  • Pierre-Benite CEDEX, France, 69495
    • Centre Hospitalier Lyon-Sud
  • Pierre-Benite CEDEX, France, 69495
    • Local Institution - 103
  • Rennes, France, 35033
    • CHRU Rennes
  • Rouen Cedex, France, 76038
    • Centre Henri Becquerel
• Germany
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Göttingen, Germany, 37099
    • UKG Universitatsklinikum Gottingen
  • Homburg-Saar, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Köln, Germany, 50924
    • Universitätsklinik Köln
  • München, Germany, 81377
    • Medizinische Klinik III Klinikum der Universität München-Großhadern
• Italy
  • Bologna, Italy, 40138
    • University of Bologna
  • Brescia, Italy, 25123
    • Spedali Civili di Brescia
  • Brescia, Italy, 25123
    • Local Institution - 306
  • Milano, Italy, 20162
    • A.O. Ospedale Ca Granda - Niguarda
  • Milano, Italy, 20144
    • IEO- Istituto Europeo di Oncologia
  • Napoli, Campania, Italy, 80131
    • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
  • Napoli, Campania, Italy, 80131
    • Local Institution - 304
  • Pavia, Italy, 27100
    • I.R.C.C.S. Policlinico San Matteo
  • Rozzano (milano), Italy, 20089
    • IRCCS Humanitas Clinical Institute
• Japan
  • Chuo-ku, Japan, 104-0045
    • National Cancer Center Hospital
  • Isehara City, Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Nagoya, Japan, 464-8681
    • Aichi Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Local Institution - 602
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Academic Medical Center, Amsterdam
  • Groningen, Netherlands, 9713 GZ
    • UMC Groningen
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus Medical Center
  • Rotterdam, Netherlands, 3015 CN
    • Local Institution - 501
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • London, United Kingdom, WC1E 6BT
    • UCL Cancer Institute
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital Nhs Trust
  • Manchester, United Kingdom, M20 4BX
    • Local Institution - 404
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust
  • Oxford, United Kingdom, 0X3 7LE
    • Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
  • Oxford, United Kingdom, 0X3 7LE
    • Local Institution - 406
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospitals NHS Trust
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Local Institution - 402
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Local Institution - 407
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Scottsdale, Arizona, United States, 85258
      • Pinnacle Oncology Hematology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Cancer Center University of Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14642
      • Local Institution - 005
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Peggy and Charles Stephenson Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical Oncology Associates
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center
    • Houston, Texas, United States, 77030-4009
      • Md Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
2. Subject who has high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
3. Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
4. Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
5. Subject who is willing and able to undergo biopsy.
6. Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
7. Subject with lymphoma who has measurable disease (≥ 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
8. Subject who fulfills the laboratory requirements as per protocol

Exclusion Criteria

1. Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
2. Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.

3. Subject who received any prior monoclonal antibodies against programmed cell death-1 (PD-1) or programmed cell death ligand-1 (PD-L1) and/or any prior:

   1. Arm A only: drugs with immunomodulatory and other properties (eg, lenalidomide, thalidomide);
   2. Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
   3. Arms C only: bendamustine
4. Subject who has active auto-immune disease.
5. Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
6. Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
7. Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
8. Subject who has history of primary immunodeficiency or tuberculosis.
9. Subject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Durvalumab + Lenalidomide ± Rituximab; Participants assigned to Arm A will receive: Durvalumab 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and; Lenalidomide orally at assigned dose levels (10 mg, 15 mg or 20 mg) once daily on Days 1 to 21 of:Cycles 1 through 13 in indolent non-Hodgkin's lymphoma (NHL) orAll cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL; Rituximab 375 mg/m² IV infusion every week in Cycle 1 (Days 2, 8, 15, 22) and on Day 1 of Cycles 2 through 5. All treatment cycles were 28 days.	Drug: Lenalidomide; Administered orally; Other Names: Revlimid®; Drug: Durvalumab; Administered as an IV infusion (250 mL) over approximately 1 hour in duration; Other Names: MEDI4736; IMFINZI®; Drug: Rituximab; Administered by intravenous infusion; Other Names: Rituxan®; MabThera®
Experimental: Arm B: Durvalumab + Ibrutinib; Participants assigned to Arm B will receive: Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13; Ibrutinib orally at assigned dose levels (280 mg, 420 mg, or 560 mg) once daily until disease progression, unacceptable toxicity or discontinuation for any other reason. All treatment cycles were 28 days.	Drug: Durvalumab; Administered as an IV infusion (250 mL) over approximately 1 hour in duration; Other Names: MEDI4736; IMFINZI®; Drug: Ibrutinib; Administered orally; Other Names: Imbruvica®
Experimental: Arm C: Durvalumab + Rituximab ± Bendamustine; Participants assigned to Arm C will receive: Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13; Rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose will be 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose); Bendamustine IV infusion at assigned dose levels (70 mg/m² or 90 mg/m²) on Days 1 and 2 of Cycles 1 through 6. All treatment cycles were 28 days.	Drug: Durvalumab; Administered as an IV infusion (250 mL) over approximately 1 hour in duration; Other Names: MEDI4736; IMFINZI®; Drug: Rituximab; Administered by intravenous infusion; Other Names: Rituxan®; MabThera®; Drug: Bendamustine; Administered as a 30-minute intravenous infusion; Other Names: Bendeka®; Treanda®; Levact®
Experimental: Arm D: Durvalumab Monotherapy; Participants assigned to Arm D will receive durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13. All treatment cycles were 28 days.	Drug: Durvalumab; Administered as an IV infusion (250 mL) over approximately 1 hour in duration; Other Names: MEDI4736; IMFINZI®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events	Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).	From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the data cut-off date of 6 March 2019. Maximum time on treatment was 55.4 weeks for DUR and 130 weeks for other study drugs.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion • Grade 4 anemia, unexplained by underlying disease • Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours. Non-Hematologic DLT • Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management • Any treatment interruption greater than 2 weeks due to adverse event.	Cycle 1 (28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Response	Time to response was calculated as the time from first dose of study drug to the first response date (CR or PR for lymphoma participants and CR, CRi, nPR, PR, or PRL for CLL participants).	From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.
Kaplan-Meier Estimate of Duration of Response	Duration of response is defined for responders only as the time from the first documented response (CR or PR for lymphoma participants or CR, CRi, nPR, PR, or PRL for CLL participants) to disease progression or death (from any cause). For participants with response but no progression, or death, duration of response was censored at the last date that the participant was known to be progression-free.	From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.
Kaplan-Meier Estimate of Progression-free Survival (PFS)	Progression-free survival was calculated as the time from first dose of study drug to the first documented progression or death (from any cause) during the entire efficacy evaluation period. For participants with no progression or death, PFS was censored at the last assessment date the participant was known to be progression-free.	From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.
Maximum Observed Plasma Concentration (Cmax) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Time to Maximum Plasma Concentration (Tmax) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Terminal Elimination Phase Half-Life (t½) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Clearance (CL) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Volume of Distribution (Vz) of Durvalumab		Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.
Maximum Observed Plasma Concentration (Cmax) of Lenalidomide		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.
Time to Maximum Observed Plasma Concentration (Tmax) of Lenalidomide		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Lenalidomide		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Ibrutinib		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.
Time to Maximum Observed Plasma Concentration (Tmax) of Ibrutinib		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Ibrutinib		Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose
Change From Baseline in Soluble Programmed Cell Death Ligand-1 (sPD-L1) Concentration	Change from baseline in sPD-L1 could not be calculated as all post-baseline samples were below the lower limit of quantification (<15.60 pg/mL).	Baseline (Cycle 1 Day 1 predose) and Day 1 of Cycles 2 to 13
Overall Response Rate (ORR) During Durvalumab Treatment	For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).	Up to 13 cycles (12 months)
Overall Response Rate During the Entire Study	For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification) (Cheson, 2014). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percentage of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).	From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): August 21, 2022

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimated): April 11, 2016

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Immune System Diseases; Lymphoma; Rituximab; Lenalidomide; Ibrutinib; Chronic Lymphocytic Leukemia; Bendamustine; Durvalumab; B-Cell Malignancies; Lymphoma, B-Cell; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Small Lymphocytic; MEDI4736; Lymphoma, Follicular; Hodgkin Disease; Anti-PD-L1 Antibody; Immune Checkpoint; Lymphoma, Mantle Cell; Lymphatic Disease; Abscopal Effect; Lymphoma, Non Hodgkin,; Leukemia, Lymphocytic, Chronic, B-Cell,; Lymphoma, Diffuse Large B-Cell
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Bendamustine Hydrochloride; Durvalumab; Rituximab
• Other Study ID Numbers: MEDI4736-NHL-001; 2015-003516-21 (EudraCT Number)