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Clinical Trial 19404

Cancer Type: Malignant Hematology
Interventions:CC-122; G-CSF; R-CHOP-21; prednisone

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Julio Chavez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

This is Phase 1/2 study of 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 CC-122 with R-CHOP could help in controlling DLBCL in this patient population.

Objective

Primary Objectives: The primary objective of the Phase 1 portion of the study is to evaluate the safety and tolerability of CC-122 in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy and the anti-CD20 monoclonal antibody rituximab (R-CHOP) given in 21-day treatment cycles (R-CHOP-21) for first-line treatment of patients with poor-risk (IPI >/= 3) DLBCL in order to identify an appropriate dose and schedule for further investigation in Phase 2. The primary objective of the Phase 2 portion of the study is to evaluate the rate of complete response (CR) when adding CC-122 to the standard R-CHOP-21 regimen in first-line treatment of patients with poor-risk DLBCL. Secondary Objectives: Phase 1: To evaluate early signals of efficacy. Phase 2: To characterize additional efficacy parameters such as progression-free survival (PFS) and overall survival (OS). To further describe the safety and tolerability associated with CC-122 in combination with R-CHOP-21 in this setting. To evaluate biomarkers which are predictive of clinical response to CC-122, when administered in combination with R-CHOP-21.

Inclusion Criteria

  • Must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Has documented, histologically locally confirmed, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) and the following histologies; refer to the World Health Organization (WHO) classification: a) DLBCL associated with chronic inflammation, b) Epstein-Barr virus positive of the elderly c) T-Cell/histiocyte-rich DLBCL.
  • Is considered an appropriate candidate (per Investigator assessment) for induction therapy with 6 cycles of R-CHOP-21 immunochemotherapy.
  • Performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale. ECOG PS of 3: may be included if decreased PS is secondary to DLBCL only, and not to comorbidities.
  • Has poor-risk disease defined as International Prognostic Index (IPI) score ≥ 3 (high-intermediate or high-risk classification) and has an age-adjusted IPI defined as > Has measurable disease on cross-sectional imaging by computed tomography (CT) with at least one (post-biopsy) measurable lesion ≥ 2.0 cm in its longest dimension.
  • Must appropriately be able to complete Screening assessments before beginning treatment for DLBCL, in the judgement of the Investigator.
  • Must meet required laboratory values
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Sufficient tissue from diagnostic tumor/ lymph node biopsy (from within 2 months prior to ICF signature) must be available for translational research purposes or participant is willing to undergo core needle or incisional/ excisional biopsy during Screening.
  • Is able to swallow pills.
  • Additional criteria may apply

  • Exclusion Criteria

  • Is seropositive for or has active viral infection with hepatitis B virus (HBV): 1.)HBV surface antigen (HBsAg) positive; 2.) HBV surface antigen (HBsAg) negative, HBV surface antibody (ant i-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA patients who are seropositive because of prior HBV vaccination are eligible (anti- HBs positive, anti-HBc negative, and HBsAg negative).
  • Known to be seropositive for, or have an active infection with, hepatitis C virus (HCV).
  • Known to be seropositive for, or have an active infection with, human immunodeficiency virus (HIV).
  • Has any neuropathy > Grade 1. 5.
  • Has impaired cardiac function or clinically significant cardiac diseases
  • Has confirmed central nervous system (CNS) involvement by DLBCL. Patients at risk for central nervous system (CNS) involvement per Investigator assessment must receive prophylaxis. For patients at risk, or with any neurological symptoms, testing for CNS involvement is required at Screening.
  • Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent participating in the study.
  • Has any condition including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study.
  • Has any condition that confounds the ability to interpret data from the study.
  • Other exclusions apply