Clinical Trial 20069

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03930953

Phase: Phase I
Principal Investigator: Chavez, Julio

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Overview

Study Title

A Phase 1, Multi-center, Open-label, Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of an Orally Available Small Molecule CC-99282 Alone and in Combination with Rituximab in Subjects with Relapsed and/or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) and Indolent Non-Hodgkin Lymphoma (R/R iNHL)

Summary

The purpose of this study is to test the safety of the new experimental drug, CC-99282. For some participants with DLBCL or FL enrolling in Part B of the study, an additional purpose is to test the safety of CC-99282 in combination with rituximab.

Objective

Primary Objectives: To determine the safety and tolerability of CC-99282 alone and in combination with rituximab in subjects with R/R NHL. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-99282 in subjects with R/R NHL. Secondary Objectives: To characterize the pharmacokinetics (PK) of CC-99282. To provide information on the preliminary efficacy of CC-99282 alone and in combination with rituximab in R/R NHL.

Treatments

Therapies

Therapy (NOS)

Medications

CC-99282 (); Rituxan (rituximab); rituximab ()

Inclusion Criteria

Participant is ≥18 years of age at the time of signing the informed consent form (ICF).

Participant has a history of NHL with relapsed or refractory disease

Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Participants must have the following laboratory values: (a) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgrastim) (b) Hemoglobin (Hgb) ≥ 8 g/dL (c) Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days (d) Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). (e) AST/SGOT and ALT/SGPT ≤ 2.5X ULN (f) Estimated serum creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation.

Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)

Exclusion Criteria

Participant has life expectancy ≤ 2 months.

Participant has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter.

Participant has symptomatic CNS involvement of disease (does not apply to PCNSL participants in Part B).

Participant is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or participants with clinically significant graft-versus-host disease (GVHD).

Participant had prior autologous SCT ≤ 3 months prior to starting CC 99282 and any treatment-related toxicity is unresolved (grade > 1).

Participant had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99282. If participant had prior allogeneic SCT > 6 months prior to the start of CC-99282, any treatment-related toxicity is unresolved (grade > 1).

Participant had major surgery ≤ 2 weeks prior to starting CC-99282. Participants must have recovered from any clinically significant effects of recent surgery

Prior radiotherapy within one month prior to starting study drug.

Known human immunodeficiency virus (HIV) infection.

Known chronic active hepatitis B or C virus (HBV/HCV) infection.

History of concurrent second cancers requiring active, ongoing systemic treatment.

. Concurrent administration of strong CYP3A4/5 modulators (see

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