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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Local Institution - 106
Phoenix, Arizona, United States
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)
Time frame: During the First cycle (each cycle is 28 days)
Recommended Phase 2 Dose (RP2D)
is defined as the dose that will be selected for dose expansion based on PK/Pd and MTD
Time frame: During the first Cycle (each cycle is 28 days)
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.
Time frame: From first dose to 28 days after last subject discontinues study treatment
Pharmacokinetics - Cmax
Maximum plasma concentration
Time frame: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)
Pharmacokinetics - Ctrough
Observed plasma concentration at the end of the dosing interval
Time frame: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)
Pharmacokinetics - AUC(TAU)
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 105
Lake Mary, Florida, United States
Local Institution - 102
Rochester, Minnesota, United States
Local Institution - 100
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Local Institution - 103
Nashville, Tennessee, United States
Local Institution - 203
Créteil, France
Local Institution - 200
Lillie Cedex, France
Local Institution - 201
Montpellier, France
Local Institution - 202
Nantes, France
...and 16 more locations
Time frame: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)
Pharmacokinetics - tmax
Time to maximum plasma concentration
Time frame: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)
Pharmacokinetics - CLT/F
Apparent total plasma clearance
Time frame: At Cycle1 Day15 and Cycle2 Day15 (each cycle is 28 days)
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
Time frame: Approximately 5 years
Complete Response Rate (CRR)
is defined as the proportion of subjects experiencing CR before receiving any subsequent anti-lymphoma therapy
Time frame: Approximately 5 years
Time to Response (TTR)
is defined as the time from enrollment dose date to the date of first documented response (≥ PR)
Time frame: Approximately 5 years
Duration of Response (DOR)
is defined as the time from first dose date to the date of first documented response (≥ PR)
Time frame: Approximately 5 years
Progression-free Survival (PFS)
is defined as the time from enrollment date to the first occurrence of disease progression or death from any cause
Time frame: Approximately 5 years
Overall Survival (OS)
is defined as the time from enrollment date to death from any cause
Time frame: Approximately 5 years