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Immunomodulator

CC-220 + Anti-CD20 mAb for Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be ≥ 18 years of age at the time of signing the informed consent form (ICF).

Subjects must have a histologically confirmed diagnosis of lymphoma according to 2016 World Health Organization (WHO) classification.

Must not have

Subjects with peripheral neuropathy ≥ Grade 2.

Subjects who have had major surgery ≤ 2 weeks prior to starting CC-220.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, CC-220, to see if it can help people with lymphoma who have not responded to other treatments.

Who is the study for?

Adults over 18 with relapsed or refractory lymphoma, who've had at least two prior treatments and have measurable disease. They must be in fairly good health (ECOG status 0-2), understand the risks of the drug potentially causing birth defects, and agree to follow strict pregnancy prevention measures if they can have children.

What is being tested?

The study is testing CC-220's safety and optimal dose alone and combined with anti-CD20 mAbs (rituximab or obinutuzumab) for treating lymphoma that has returned after treatment. It includes an initial phase to find the best dose followed by a second phase to confirm its effectiveness.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression, nerve damage symptoms like numbness or tingling (peripheral neuropathy), increased risk of blood clots, allergic reactions to similar drugs previously taken, or other significant medical issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lymphoma diagnosis is confirmed by lab tests, as per WHO standards.

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I am able to care for myself and perform daily activities.

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My lymphoma has returned or didn't respond to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage.

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I have not had major surgery within the last 2 weeks.

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I am HIV positive.

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I had a stem cell transplant less than 3 months ago or have ongoing side effects.

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I have previously been treated with the drug CC-99282.

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My cancer has spread to my brain or is suspected to.

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I have been diagnosed with lymphoblastic lymphoma.

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I have chronic active hepatitis B.

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I am unable or unwilling to follow the required blood clot prevention treatment.

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I have a serious heart condition.

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I do not have any major health issues that would stop me from joining the study.

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I am on long-term immunosuppressive medication or steroids.

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My aggressive lymphoma has returned and needs urgent treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Adverse Events (AEs)

Best Overall Response Rate (ORR)

Complete Response Rate (CRR)

+9 more

Side effects data

From 2021 Phase 2 trial • 289 Patients • NCT03161483

20%

Neutropenia

19%

Urinary tract infection

19%

Upper respiratory tract infection

12%

Leukopenia

12%

Nasopharyngitis

10%

Diarrhoea

10%

Influenza

Anaemia

Nausea

Bronchitis

Back pain

Hypertension

Sinusitis

Lymphopenia

Pharyngitis

Pruritus

Headache

Pneumonia

Vomiting

Pyrexia

COVID-19

Gastroenteritis

Hypertriglyceridaemia

Limb injury

Oral herpes

Dyspnoea

Tinnitus

Abscess limb

Joint injury

Forearm fracture

Radius fracture

Polyneuropathy

Proteinuria

Chronic obstructive pulmonary disease

Oropharyngeal pain

Cellulitis

Gastroenteritis viral

Influenza like illness

Lower respiratory tract infection

Joint instability

Epistaxis

Abdominal pain upper

COVID-19 pneumonia

Uterine haemorrhage

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

0.45mg QD

0.15mg QD

Active Treatment Phase 0.30mg Following Placebo

0.30mg QD

Active Treatment Phase 0.45mg Following Placebo

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Cohort G - CC-220 plus obinutuzumab in participants with follicular lymphoma grade 1-3aExperimental Treatment2 Interventions

Group II: Cohort F - CC-220 and rituximab with follicular lymphoma grade 1-3aExperimental Treatment2 Interventions

Group III: Cohort E - CC-220 and rituximab in participants with aggressive B-cell lymphomaExperimental Treatment2 Interventions

Group IV: Cohort D -CC-220 monotherapy in participants with aggressive B-cell lymphoma and follicular lymphomaExperimental Treatment1 Intervention

Group V: Cohort C - CC-220 and obinutuzumab in R/R FL or MZL subjectsExperimental Treatment2 Interventions

Subjects 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.

Group VI: Cohort B- CC-220 and rituximab in R/R B-Cell NHL subjectsExperimental Treatment2 Interventions

Subjects 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.

Group VII: Cohort A- Monotherapy in R/R lymphoma subjectsExperimental Treatment1 Intervention

Subjects 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Obinutuzumab

2014

Completed Phase 3

~3470