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LymphomaPhase 1NCT04464798

A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas

A Phase 1 study testing CC-220, Rituximab and Obinutuzumab in people with Lymphoma, run by Celgene at 26 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
CC-220, Rituximab and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
26 sitesin 6 countries
Study dates
11 Nov 2020to 9 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Has histologically confirmed (per local evaluation) diagnosis of lymphoma according to 2016 World Health Organization (WHO) classification including:
  • Cohort A: all subtypes including B-cell, T-cell and Natural killer (NK)-cell Non-Hodgkin lymphoma (NHL), and Classical Hodgkin lymphoma (cHL).
  • Cohort B: all B-cell NHL.
  • Cohort C: FL Grade 1-3a and MZL including extranodal marginal zone lymphoma (ENMZL) of mucosa-associated lymphoid tissue (MALT lymphoma), nodal marginal zone lymphoma (NMZL) and splenic marginal zone lymphoma (SMZL)
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  • Cohort D: aggressive B-cell lymphoma and FL grade 1-3a
  • Cohort E: aggressive B-cell lymphoma including DLBCL NOS, high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements, Grade 3b FL and PMBCL
  • Cohorts F and G: FL Grade 1 to 3a
  • Relapsed or refractory disease according to the following definitions:
  • Aggressive B-cell lymphoma
  • Follicular lymphoma (FL) and Marginal zone lymphoma (MZL): following at least 2 prior lines of systemic therapy (being previously exposed to at least 1 anti-CD20 mAb and 1 alkylating agent).
  • Mantle cell lymphoma (MCL): following at least 2 prior lines of therapy including at least 1 immunochemotherapy and 1 bruton tyrosine kinase (BTK) inhibitor.
  • Peripheral T-cell lymphoma (PTCL): following at least 2 prior lines of therapy OR after 1 prior line of standard therapy and being not eligible for any other approved regimen.
  • Classical Hodgkin lymphoma (cHL): following at least 2 prior systemic lines of therapy and previously exposed to brentuximab vedotin and anti-PD1.
  • All other subtypes: following at least 2 prior lines of therapy.
  • Subjects previously treated with CAR-T therapy can be enrolled (irrespective of the indication).
  • Subjects must not be eligible for any other approved treatment for their underlying lymphoma as assessed by the Investigator.
  • Must have measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 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. Site of measurable disease cannot be previously irradiated.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Must have the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L
  • Hemoglobin (Hb) ≥ 8 g/dL.
  • Platelets (Plt) ≥ 75 x 109/L or ≥ 50 x 109/L
  • Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN.
  • Serum total bilirubin ≤ 1.5 ULN except in cases of Gilbert's syndrome, then ≤ 3.0 ULN.
  • Estimated serum creatinine clearance of ≥ 50 mL/min
  • All subjects must:
  • Have an understanding that the study drug could have a potential teratogenic risk.
  • Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
  • Females of childbearing potential (FCBP1) must:
  • Have 2 negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.
  • Male subjects must:
  • Practice true abstinence2 or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study,

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Any significant medical condition, active infection (including severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2) suspected or confirmed, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Life expectancy ≤ 3 months.
  • Diagnosis of lymphoblastic lymphoma.
  • Aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).
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  • Prior Grade 3 or 4 infusion related reaction with rituximab (for Cohorts B, E and F) or obinutuzumab (for Cohorts C and G).
  • Prior therapy with the cereblon-modulating drug CC-99282.
  • Chronic systemic immunosuppressive therapy or corticosteroids.
  • Prior ASCT ≤ 3 months prior to starting CC-220 or > 3 months AND with unresolved, Grade > 1, treatment-related toxicity.
  • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-220 or > 6 months with unresolved, Grade > 1, treatment-related toxicity.
  • Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or obinutuzumab.
  • Known allergy to thalidomide, pomalidomide or lenalidomide.
  • Inability or unwilling to undergo protocol required thromboembolism prophylaxis.
  • Major surgery ≤ 2 weeks prior to starting CC-220;
  • Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
  • Documented or suspected central nervous system (CNS) involvement of disease.
  • Subject with clinically significant cardiac disease.
  • Known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
  • Known chronic active hepatitis B
  • History of other malignancy, unless the subject has been free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:
  • Incidental histologic finding of prostate cancer (or prostate cancer that has been treated with curative intent
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

United States6 sites

  • Local Institution - 105

    Lake Mary, Florida, 32746

  • Local Institution - 103

    Nashville, Tennessee, 37203

  • Local Institution - 100

    New York, New York, 10065

  • Local Institution - 106

    Phoenix, Arizona, 85054

  • Local Institution - 102

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

Other trials in United States

France6 sites

  • Local Institution - 203

    Créteil, 94010

  • Local Institution - 200

    Lillie Cedex, 59037

  • Local Institution - 201

    Montpellier, 34295

  • Local Institution - 202

    Nantes, 44093

  • Local Institution - 204

    Paris, 75010

  • Local Institution - 205

    Pessac, 33604

Other trials in France

Germany4 sites

  • Local Institution - 401

    Berlin, 12203

  • Local Institution - 402

    Leipzig, 4103

  • Local Institution - 403

    Münster, 48149

  • Local Institution - 404

    Würzburg, 97080

Other trials in Germany

Italy4 sites

  • Local Institution - 300

    Brescia, 25123

  • Local Institution - 303

    Milan, 20133

  • Local Institution - 301

    Pavia, 27100

  • Local Institution - 302

    Verona, 37134

Other trials in Italy

South Korea3 sites

  • Local Institution - 502

    Seoul, 03722

  • Local Institution - 501

    Seoul, 06351

  • Local Institution - 500

    Seoul, 5505

Other trials in South Korea

Taiwan3 sites

  • Local Institution - 600

    Niaosong District Kaohsiung City, 83301

  • Local Institution - 601

    Taoyuan City, 33305

  • Local Institution - 602

    Taoyuan City, 40447

Other trials in Taiwan

About this study

Official title: A Phase 1/2, Multicenter, Open-label Study to Assess Safety, Pharmacokinetics, and Preliminary Efficacy of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas.

This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification.

Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

Conditions
Lymphoma
Being tested
CC-220, Rituximab, Obinutuzumab
Keywords
Relapsed or Refractory Lymphomas, Lymphomas, CC-220, Anti-CD20, Monoclonal Antibody, Pharmacokinetics, Safety
Medical subject headings
Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04464798
Study groupRoleWhat they receive
Cohort A- Monotherapy in R/R lymphoma subjectsExperimentalSubjects with Relapsed or Refractory (R/R) lymphoma who have been allocated to Cohort A will receive CC-220 monotherapy (MonoT). Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle, up to PD or a maximum of 24 cycles.
Receives: Drug: CC-220
Cohort B- CC-220 and rituximab in R/R B-Cell NHL subjectsExperimentalSubjects with R/R B-cell Non Hodgkin Lymphoma (NHL) who have been allocated to Cohort B will receive CC-220 in combination with rituximab. * Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle up to PD or maximum 24 cycles. * Rituximab will be administered at 375 mg/m2 IV at C1D1 and then on D8, D15, and D22 of C1 and then every 28-day cycle at D1 from C2 to C5, either by SC administration at a dose of 1400 mg or by IV infusion at a dose of 375 mg/m2.
Receives: Drug: CC-220; Drug: Rituximab
Cohort C - CC-220 and obinutuzumab in R/R FL or MZL subjectsExperimentalSubjects with R/R FL (Grade 1 to 3a) or MZL who have been allocated to Cohort C will receive CC-220 in combination with obinutuzumab. * Oral CC-220 at dose specified by cohort dose level from Day 1 to 21 of each 28-day cycle, up to PD or a maximum of 12 cycles. * Obinutuzumab will be administered at 1000 mg at C1D1, D8, and D15, and on D1 of every 28-day cycle from C2 to C6.
Receives: Drug: CC-220; Drug: Obinutuzumab
Cohort D -CC-220 monotherapy in participants with aggressive B-cell lymphoma and follicular lymphomaExperimentalNot described
Receives: Drug: CC-220
Cohort E - CC-220 and rituximab in participants with aggressive B-cell lymphomaExperimentalNot described
Receives: Drug: CC-220; Drug: Rituximab
Cohort F - CC-220 and rituximab with follicular lymphoma grade 1-3aExperimentalNot described
Receives: Drug: CC-220; Drug: Rituximab
Cohort G - CC-220 plus obinutuzumab in participants with follicular lymphoma grade 1-3aExperimentalNot described
Receives: Drug: CC-220; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    is defined as the dose that satisfies the escalation with overdose control (EWOC) criterion that the posterior probability to have excessive toxicity is less than 25% and has the highest probability of dose-limiting toxicity (DLT) rate being in the target interval (0.16 to 0.33)

    Measured: During the First cycle (each cycle is 28 days)

  2. Recommended Phase 2 Dose (RP2D)

    is defined as the dose that will be selected for dose expansion based on PK/Pd and MTD

    Measured: During the first Cycle (each cycle is 28 days)

Secondary outcomes (12)

  1. Adverse Events (AEs)

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

    Measured: From first dose to 28 days after last subject discontinues study treatment

  2. Pharmacokinetics - Cmax

    Maximum plasma concentration

    Measured: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)

  3. Pharmacokinetics - Ctrough

    Observed plasma concentration at the end of the dosing interval

    Measured: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)

  4. Pharmacokinetics - AUC(TAU)

    Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval

    Measured: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)

  5. Pharmacokinetics - tmax

    Time to maximum plasma concentration

    Measured: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)

  6. Pharmacokinetics - CLT/F

    Apparent total plasma clearance

    Measured: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)

  7. Best Overall Response Rate (ORR)

    is defined as the proportion of subjects with best overall response as either CR or partial response (PR) before subsequent anti-lymphoma therapy

    Measured: Approximately 5 years

  8. Complete Response Rate (CRR)

    is defined as the proportion of subjects experiencing CR before receiving any subsequent anti-lymphoma therapy

    Measured: Approximately 5 years

  9. Time to Response (TTR)

    is defined as the time from enrollment dose date to the date of first documented response (≥ PR)

    Measured: Approximately 5 years

  10. Duration of Response (DOR)

    is defined as the time from first dose date to the date of first documented response (≥ PR)

    Measured: Approximately 5 years

  11. Progression-free Survival (PFS)

    is defined as the time from enrollment date to the first occurrence of disease progression or death from any cause

    Measured: Approximately 5 years

  12. Overall Survival (OS)

    is defined as the time from enrollment date to death from any cause

    Measured: Approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start11 Nov 2020
  3. Primary completion31 Jan 2023
  4. Study completion9 Jan 2025

Why it stopped: Business objectives have changed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464798
Sponsor's protocol ID
CC-220-NHL-001
Other IDs
U1111-1254-1772, 2020-000354-10
Status last verified
Apr 2025
First submitted
6 Jul 2020
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-220, Rituximab and Obinutuzumab in people with Lymphoma, run by Celgene at 26 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, France, Germany, Italy, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: During the First cycle (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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