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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Celgene
Study ID
NCT04464798
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-220 — DRUG
    Oral
  • Rituximab — DRUG
    SC and IV infusion
  • Obinutuzumab — DRUG
    IV Infusion

Study Details

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).

Key Dates

Start date
Nov 11, 2020
Status verified
Apr 2025
Primary completion
Jan 31, 2023
Completion
Jan 9, 2025

Study Design

Enrollment
62 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A- Monotherapy in R/R lymphoma subjects
    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.
  • Experimental: Cohort B- CC-220 and rituximab in R/R B-Cell NHL subjects
    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.
  • Experimental: Cohort C - CC-220 and obinutuzumab in R/R FL or MZL subjects
    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.
  • Experimental: Cohort D -CC-220 monotherapy in participants with aggressive B-cell lymphoma and follicular lymphoma
  • Experimental: Cohort E - CC-220 and rituximab in participants with aggressive B-cell lymphoma
  • Experimental: Cohort F - CC-220 and rituximab with follicular lymphoma grade 1-3a
  • Experimental: Cohort G - CC-220 plus obinutuzumab in participants with follicular lymphoma grade 1-3a

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: During the First cycle (each cycle is 28 days) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Local Institution - 106PhoenixArizona85054-
Local Institution - 105Lake MaryFlorida32746-
Local Institution - 102RochesterMinnesota55905-
Local Institution - 100New YorkNew York10065-
University of Rochester Cancer CenterRochesterNew York14642-
Local Institution - 103NashvilleTennessee37203-

Find similar trials in Phoenix, AZ

By research site
Local Institution - 106· Phoenix, AZLocal Institution - 105· Lake Mary, FLLocal Institution - 102· Rochester, MNLocal Institution - 100· New York, NYUniversity of Rochester Cancer Center· Rochester, NYLocal Institution - 103· Nashville, TN

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