Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma

A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated Aggressive B-cell Lymphoma

This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, B-Cell
• Intervention / Treatment: Drug: CC-220; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: CC-99282; Drug: Rituximab; Drug: Rituximab; Drug: Polatuzumab vedotin

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT # and Site #.

Study Locations

• Australia
  • Perth, Australia, WA 6000
    • Recruiting
    • Local Institution - 503
    • Contact: Site 503
  • Waratah, Australia, NSW
    • Withdrawn
    • Local Institution - 502
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Local Institution - 501
      • Contact: Site 501
• Greece
  • Athens, Greece, 11 527
    • Recruiting
    • General Hospital of Athens "Laiko"
    • Contact: Theodoros Vassilakopoulos, Site 704; Phone Number: +00302107456902
  • Athens, Greece, 10676
    • Recruiting
    • Local Institution - 702
    • Contact: Site 702
  • Athens, Greece, 12464
    • Recruiting
    • Local Institution - 701
    • Contact: Site 701
  • Patras, Greece, 26500
    • Withdrawn
    • Local Institution - 703
  • Thessaloniki, Greece, 57010
    • Recruiting
    • Georgios Papanikolaou General Hospital of Thessaloniki
    • Contact: Ioanna Sakellari, Site 700
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Local Institution - 300
    • Contact: Site 300
  • Seoul, Korea, Republic of, 3080
    • Recruiting
    • Local Institution - 301
    • Contact: Site 301
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Local Institution - 302
    • Contact: Site 302
• Poland
  • Gdansk, Poland, 80-952
    • Recruiting
    • Local Institution - 601
    • Contact: Site 601
  • Krakow, Poland, 30-727
    • Recruiting
    • MCM Krakow - PRATIA - PPDS
    • Contact: Wojciech Jurczak, Site 600; Phone Number: +48602338290
  • Poznan, Poland, 60-185
    • Withdrawn
    • Local Institution - 0706
  • Poznan, Poland, 60-185
    • Withdrawn
    • Local Institution - UNK0706
  • Poznan, Poland, 60-185
    • Recruiting
    • Centrum Medyczne Pratia Poznan
    • Contact: Michal Kwiatek, Site 605; Phone Number: 48793602210
  • Slomniki, Poland, 32-090
    • Recruiting
    • Sp Zoz Szpital Uniwersytecki W Krakowie
    • Contact: Dagmara Zimowska-Curylo, Site 603; Phone Number: +48122954139
  • Warsaw, Poland, 02-781
    • Recruiting
    • Local Institution - 602
    • Contact: Site 602
  • Wroclaw, Poland, 50-367
    • Recruiting
    • Local Institution - 604
    • Contact: Site 604
• Spain
  • Barcelona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol ICO Badalona
    • Contact: Juan Manuel Sancho, Site 201; Phone Number: +34934978987
  • Madrid, Spain, 28007
    • Withdrawn
    • Local Institution - 204
  • Málaga, Spain, 29010
    • Recruiting
    • H. Virgen de la Victoria
    • Contact: Antonio Rueda-Domínguez, Site 203; Phone Number: +34951032467 00 000
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
    • Contact: Alejandro Martin Garcia-Sancho, Site 200; Phone Number: +34980548200
• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • Local Institution - 403
    • Contact: Site 403
  • Taichung, Taiwan, 407219
    • Recruiting
    • Local Institution - 402
    • Contact: Site 402
  • Taipei, Taiwan, 100229
    • Recruiting
    • Local Institution - 400
    • Contact: Site 400
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic - Arizona
      • Contact: Javier Munoz, Site 154; Phone Number: 480-301-8000
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Withdrawn
      • Mayo Clinic - Jacksonville
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville - PPDS
      • Contact: Muhamad Alhaj Moustafa, Site 160; Phone Number: 904-953-2000
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Marc Hoffmann, Site 159; Phone Number: 913-574-2650
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic - Rochester
      • Contact: Grzegorz Nowakowski, Site 152; Phone Number: 507-284-2511
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska - Fred and Pamela Buffet Center
      • Contact: Matthew Lunning, Site 151; Phone Number: 402-559-7164
  • New York
    • Buffalo, New York, United States, 14263
      • Withdrawn
      • Roswell Park Cancer Institute
  • Texas
    • Houston, Texas, United States, 77003
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Jason Westin, Site 155; Phone Number: 713-792-3750

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants must satisfy the following criteria to be enrolled in the study:

  1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
  3. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
  4. Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
  5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  6. Participants must have the following laboratory values:

     1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)
     2. Hemoglobin (Hb) ≥ 8 g/dL
     3. Platelets (PLT) ≥ 75 x 109/L or ≥ 50 x 109/L in case of documented bone marrow involvement (>50% or tumor cells), without transfusion for 7 days
     4. Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0 x ULN.
     5. Serum total bilirubin ≤ 2.0 mg/dL except in cases of Gilbert's syndrome, then ≤ 5.0 mg/dl. Subjects receiving polatuzumab vedotin must have serum total bilirubin < 1.5 × ULN (26 μmol/L) (corresponding to mild degree as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria) except in cases of Gilbert's syndrome, then ≤ 3.0 mg/dl (51 μmol/L).
     6. Estimated serum creatinine clearance (CrCl) of ≥ 50 mL/min using the modification of diet in renal disease (MDRD) formula.

  7. All participants must:

     1. Have an understanding that the study drug could have a potential teratogenic risk.
     2. Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in Clinical trials.

  8. Females of childbearing potential (FCBP) must:

     a. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy.

  9. Male participants must:

     1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.

Exclusion Criteria:

• The presence of any of the following will exclude a participant from enrollment:

  1. Any significant medical condition, active infection (including SARS-CoV-2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  2. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
  3. Any other subtype of lymphoma.
  4. Documented or suspected CNS involvement by lymphoma.
  5. Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
  6. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
  7. Subjects with a history of progressive multifocal leukoencephalopathy.
  8. Chronic systemic immunosuppressive therapy or corticosteroids

  9. Impaired cardiac function or clinically significant cardiac disease, including any of the following:

     a. Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)

  10. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery.
  11. Any condition causing inability to swallow tablets.
  12. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV)
  13. Known chronic active hepatitis B (hepatitis B virus surface antigen [HBsAg] positive and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or C (positive serology requiring treatment and/or with evidence of liver damage) infection

  14. History of other malignancy, unless being free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:

      1. Localized nonmelanoma skin cancer
      2. Carcinoma in situ of the cervix
      3. Carcinoma in situ of the breast
      4. Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer that has been treated with curative intent.
  15. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or polatuzumab vedotin.
  16. Known hypersensitivity to any component of CHOP/CHP regimen.
  17. Known allergy to thalidomide, pomalidomide, or lenalidomide.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-220 with R-CHOP-21; CC-220 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment	Drug: CC-220; CC-220 by mouth at the assigned dose starting on Day 1 for 14 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.; Other Names: BMS-986382; Iberdomide; Drug: Cyclophosphamide; Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Doxorubicin; Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Vincristine; Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) IV intravenous on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Prednisone; Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles; Other Names: Prednisolone; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
Experimental: Administration of CC-99282 with R-CHOP-21; CC-99282 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment	Drug: Cyclophosphamide; Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Doxorubicin; Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Vincristine; Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) IV intravenous on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Prednisone; Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles; Other Names: Prednisolone; Drug: CC-99282; CC-99282 by mouth at the assigned dose starting on Day 1 for 7 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.; Other Names: BMS-986369; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
Experimental: Administration of CC-220 with polatuzumab-R-CHP; CC-220 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment	Drug: CC-220; CC-220 by mouth at the assigned dose starting on Day 1 for 14 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.; Other Names: BMS-986382; Iberdomide; Drug: Cyclophosphamide; Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Doxorubicin; Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Prednisone; Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles; Other Names: Prednisolone; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Polatuzumab vedotin; Polatuzumab vedotin 1.8 mg/kg on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
Experimental: Administration of CC-99282 with polatuzumab-R-CHP; CC-99282 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment	Drug: Cyclophosphamide; Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Doxorubicin; Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Prednisone; Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles; Other Names: Prednisolone; Drug: CC-99282; CC-99282 by mouth at the assigned dose starting on Day 1 for 7 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.; Other Names: BMS-986369; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Rituximab; Rituximab 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles; Drug: Polatuzumab vedotin; Polatuzumab vedotin 1.8 mg/kg on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase 2 Dose (RP2D) - Part 1	Defined as the dose that will be selected for dose expansion based on MTD	During the first cycle of treatment (each cycle is 21 days)
Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2	AEs evaluated using NCI CTCAE criteria, v. 5.0, including treatment -emergent adverse events (TEAEs) and laboratory assessments	From the first dose of any IP until 28 days after the last dose of IP
Maximum Tolerated Dose (MTD) - Part 2A	Frequency of DLTs associated with addition of iberdomide (CC-220) to polatuzumab-R-CHP therapy and the addition of CC-99282 to polatuzumab-R-CHP therapy	During the first cycle of treatment (each cycle is 21 days)
Recommended Phase 2 Dose (RP2D) - Part 2A	Defined as the dose that will be selected for dose expansion based on MTD	During the first cycle of treatment (each cycle is 21 days)
Maximum Tolerated Dose (MTD) - Part 1	Frequency of dose-limiting toxicities (DLT) associated with addition of iberdomide (CC-220) to R-CHOP-21 therapy and the addition of CC-99282 to R-CHOP-21 therapy	During the first 2 cycles of treatment (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best overall response rate (ORR)	The proportion of participants with best overall response achieved during the study as either Complete Response or Partial Response before subsequent anti-lymphoma therapy	Up to 4 years
Complete Metabolic Response Rate (CMRR)	The proportion of participants experiencing complete metabolic response (CMR) before receiving any subsequent anti-lymphoma therapy	Up to 4 years
Time to Response (TTR)	The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to the date of first documented response (≥ PR)	Up to 4 years
Duration of Response (DOR)	The time from the earliest date of documented response (≥ PR) to the first occurrence of relapse or progression	Up to 4 years
Progression-free Survival (PFS)	The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to the first occurrence of disease progression or death from any cause	Up to 4 years
Overall Survival (OS)	The time from entry to the study (enrollment date for Part 1 and randomization date for Part 2) to death from any cause	Up to 4 years
Pharmacokinetics - Cmax for CC-220	Maximum plasma concentration of drug	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days)
Pharmacokinetics - Ctrough for CC-220	Minimum or trough concentration	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days
Pharmacokinetics - Tmax for CC-220	Time to maximum plasma concentration	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days
Pharmacokinetics - Cmax for CC-99282	Maximum plasma concentration	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days
Pharmacokinetics - Ctrough for CC-99282	Minimum or trough concentration	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days
Pharmacokinetics - Tmax for CC-99282	Time to maximum plasma concentration	At Cycle 1 Day 7, Cycle 1 Day 15, and Cycle 2 Day 7 (each cycle is 21 days

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): September 15, 2021
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): February 4, 2026

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; Iberdomide; CC-220; B-Cell Lymphoma; CC-99282
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Immunoconjugates; Prednisolone; Cyclophosphamide; Rituximab; Prednisone; Doxorubicin; Vincristine; Polatuzumab vedotin
• Other Study ID Numbers: CC-220-DLBCL-001; 2020-005705-71 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No