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

Official Title

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


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.

Trial Description

Primary Outcome:

  • Maximum Tolerated Dose/Maximum Administered Dose (MTD/MAD) (Phase 1)
  • Complete Response Rate (CRR); Percentage of participants experiencing positron emission tomography (PET)-negative complete response (CR) (Phase 2)
Secondary Outcome:
  • Overall Response Rate (ORR); Percentage of participants who achieve a PR or CR according to the Lugano criteria.
  • ORR by Predictive Gene Signature
  • Progression-free Survival (PFS)
  • Event-free Survival (EFS)
  • Overall Survival (OS)
  • Adverse Events (AEs)
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.

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