NCT03283202

Study of Safety and Efficacy of Avadomide (CC-122) Combined With RCHOP for Newly-diagnosed DLBCL With Poor Risk Factors

A Phase 1/2 Open-Label Multicenter Study of Avadomide (CC-122) in Combination With R-CHOP-21 for Previously Untreated Poor Risk (IPI>=3) Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is Phase 1/2 study of avadomide (CC-122) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, for first-line treatment of patients with Diffuse B-Cell Large B-Cell Lymphoma (DLBCL) that has poor risk factors. Approximately 40% of patients diagnosed with DLBCL are not cured with R-CHOP alone and would need additional treatment for DLBCL in the future. The addition of the experimental drug avadomide (CC-122) with R-CHOP could help in controlling DLBCL in this patient population.

Detailed description

This research study is for patients who have been newly diagnosed with diffuse large B-cell lymphoma DLBCL and are receiving treatment for the first time. This study will be conducted in two phases. Phase 1 will test the safety of increasing dose levels of avadomide (CC-122) when given in combination with R-CHOP-21 therapy to identify an appropriate dose and schedule for further evaluation in Phase 2. Phase 2 will evaluate the rate of complete response when adding avadomide (CC-122) to the R-CHOP-21 regimen in first-line treatment of patients with poor risk DLBCL. This study is separated into three periods: the Screening period, the Treatment period and the Follow-up period. Before the patient can receive the drug the doctor will perform test to find out whether he/she can participate in the study. This is done during the Screening period. If the patient and the treating physician determine that the patient is eligible to participate in the study, the patient will be registered in the study and receive avadomide (CC-122) combined with R-CHOP. In the Treatment period the patient will receive treatment for up to 6 treatment cycles. Each treatment cycle is 21 days long. The full length of the treatment period will be approximately 4 months. The follow-up period begins when the patient has completed treatment or is discontinued for any reason. During the follow-up period the patient will have fewer exams, test and visits. The first follow-up visit will be 28 days after treatment is completed or discontinued. After that, the follow-up visits will be every 3 months during the first year, then every 6 months until the study is closed. Upon completion of the Phase 1 portion of the study, a decision not to proceed with the Phase 2 portion was taken by the Sponsor. The decision to terminate the study after Phase 1 was not based on any safety concerns that posed an unacceptable risk for this patient population and no safety issues have been identified

Conditions

• Diffuse B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Avadomide (CC-122)	Avadomide (CC-122) by mouth at the assigned dose in Ph 1 starting on Day 1 for 5 consecutive days per week, followed by 2 days without avadomide (CC-122) administration (5/7) for the first two weeks of a 21-day treatment cycle. If the highest proposed dose level to be explored in Phase 1 is applied, the dosing regimen will be 5/7 days for all 3 weeks of each 21-day treatment cycle.
DRUG	Rituximab	Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
DRUG	Cyclophosphamide 750mg/m2 by IV infusion	Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
DRUG	Vincristine	Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) on Day 1 by IV bolus on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
DRUG	Prednisone	Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles

Timeline

• Start date: 2017-10-04
• Primary completion: 2019-07-30
• Completion: 2020-12-16
• First posted: 2017-09-14
• Last updated: 2021-04-29

Locations

15 sites across 4 countries: United States, Belgium, Canada, Spain

Regulatory

• FDA-regulated drug study