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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
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
17%
Urinary tract infection
14%
Upper respiratory tract infection
14%
Vomiting
14%
Diarrhoea
12%
Pharyngitis
12%
Nasopharyngitis
10%
Bronchitis
10%
Influenza
10%
Oral herpes
7%
Leukopenia
7%
Nausea
7%
Hypertriglyceridaemia
7%
Pyrexia
7%
Headache
7%
Anaemia
5%
Abdominal pain upper
5%
Back pain
5%
Hypertension
5%
Neutropenia
2%
Pruritus
2%
Cholangitis
2%
Septic shock
2%
Suture related complication
2%
Cardiac tamponade
2%
Implant site pain
2%
Traumatic fracture
2%
Sinusitis
2%
Osteoarthritis
2%
Oropharyngeal pain
2%
Acute kidney injury
2%
Pericarditis
2%
Cholelithiasis
2%
Ischaemic stroke
2%
Abnormal uterine bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.15mg QD
0.30mg QD
0.45mg QD
Active Treatment Phase 0.30mg Following Placebo
Active Treatment Phase 0.45mg Following Placebo
Placebo

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
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
CC-220
2016
Completed Phase 2
~620

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,909 Total Patients Enrolled
87 Trials studying Lymphoma
9,729 Patients Enrolled for Lymphoma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,468 Total Patients Enrolled
53 Trials studying Lymphoma
10,348 Patients Enrolled for Lymphoma
Vijaya Kesanakurthy, M.DStudy DirectorCelgene/BMS

Media Library

CC-220 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04464798 — Phase 1
CC-220 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464798 — Phase 1
Lymphoma Research Study Groups: Cohort C - CC-220 and obinutuzumab in R/R FL or MZL subjects, Cohort G - CC-220 plus obinutuzumab in participants with follicular lymphoma grade 1-3a, Cohort B- CC-220 and rituximab in R/R B-Cell NHL subjects, Cohort F - CC-220 and rituximab with follicular lymphoma grade 1-3a, Cohort A- Monotherapy in R/R lymphoma subjects, Cohort E - CC-220 and rituximab in participants with aggressive B-cell lymphoma, Cohort D -CC-220 monotherapy in participants with aggressive B-cell lymphoma and follicular lymphoma
Lymphoma Clinical Trial 2023: CC-220 Highlights & Side Effects. Trial Name: NCT04464798 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being recruited for this clinical trial?

"This trial necessitates 232 participants that meet the established criteria. Those interested in joining can do so at Mayo Clinic located in Rochester, Minnesota and Lake Mary DDU Florida Cancer based out of Lake Mary, Florida."

Answered by AI

Is the recruitment phase of this research endeavor still available?

"Correct. Clinicaltrials.gov indicates that since its posting on November 11th 2020, this clinical trial has been searching for 232 participants from 6 different sites. It was recently updated on October 19th 2022"

Answered by AI

What is the goal of this experiment?

"As reported by the trial sponsor, Celgene, Maximum Tolerated Dose (MTD) is the primary outcome which will be assessed in a span of 28 days. Additionally, Adverse Events (AEs), Overall Survival (OS), and Pharmacokinetics - Cmax are being evaluated as secondary results. AEs refer to any medical occurrence that can affect or worsen the subject's health while OS stands for time from enrollment date until death due to any cause. Lastly, Cmax refers to maximum plasma concentration."

Answered by AI

Have there been any other experiments using CC-220 in a clinical setting?

"CC-220 was initially studied in 1993 by the NIH Clinical Centre situated at 9000 Rockville Pike. To date, there have been 851 completed clinical trials with 500 currently active trials mainly taking place in Rochester, Minnesota."

Answered by AI

In what locales is this clinical research taking place?

"Currently, there are 6 clinics in total across the nation that are conducting this trial. These locations include Rochester, Lake Mary and Nashville as well as 3 other sites. It is advised to choose a clinic close by so you can limit travelling expenses if chosen for participation."

Answered by AI

What therapeutic purpose does CC-220 most often serve?

"CC-220 is a popular remedy for treating diffuse large b-cell lymphoma (dlbcl). It can also combat various other illnesses including b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

Has the FDA sanctioned CC-220 for therapeutic use?

"Given the limited research data available, CC-220 was rated a '1' in terms of safety. This indicates that it is currently undergoing Phase 1 clinical trials to further assess its efficacy and safety profiles."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04464798.
~14 spots leftby Apr 2025
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