NCT03930953|Active Not RecruitingPhase 1FDA Drug

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).

Celgene ClinicalTrials.gov

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2 other identifiers

CC-99282-NHL-0012018-003235-29

Study Type

interventional

Target

438

Locations

15 countries

Sites

Timeline

RegisteredApr 2019

StartedMay 2019

CompletionFeb 2028

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

438

participants targeted

Target at P75+ for phase_1

Timeline

21mo left

Started May 2019

Longer than P75 for phase_1

Geographic Reach

15 countries

66 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.7 years study duration

Study Progress80%

May 2019Feb 2028

First Submitted

Initial submission to the registry

April 16, 2019

Completed

13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed

21 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2027

Expected

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

7.9 years

First QC Date

April 16, 2019

Last Update Submit

February 17, 2026

Conditions

Lymphoma, Non-Hodgkin

Keywords

Non-Hodgkin Lymphomas (NHL)SafetyEfficacyCC-99282RituximabRelapsedRefractoryPharmacokineticsObinutuzumabTafasitamabValemetostatAnti-lymphoma agents

Outcome Measures

Primary Outcomes (9)

Incidence of Adverse Events (AEs)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with laboratory abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with vital sign abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with electrocardiogram (ECG) abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with physical examination abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Dose Limiting Toxicity (DLT)
Up to 28 days in Cycle 1
Maximum tolerated dose (MTD)
Up to 28 days in cycle 1

Secondary Outcomes (16)

Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
+11 more secondary outcomes

Study Arms (2)

Part A: Dose Escalation

EXPERIMENTAL

Drug: CC-99282

Part B: Dose Expansion

EXPERIMENTAL

Drug: CC-99282Drug: RituximabDrug: ObinutuzumabDrug: TafasitamabDrug: Valemetostat