Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-009098
NCT ID: NCT02031419
Sponsor Protocol Number: CC-122-DLBCL-001
About this study
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Biopsy proven Diffuse large B-cell lymphoma (DLBCL) (including transformed low grade lymphoma)
- Relapsed or refractory to prior standard treatment regimens
- At least one site of measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Subjects must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L (with bone marrow involvement with DLBCL)
- Hemoglobin (Hgb) ≥ 8 g/dL.
- Platelets ≥ 50 x 109/L without transfusion for 7 days.
- Potassium within normal limits
- Asparate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 X ULN if liver tumor is present.
- Serum bilirubin ≤ 1.5 x ULN.
- Estimated serum creatinine clearance of ≥ 50 mL/min
- Symptomatic central nervous system involvement.
- Known symptomatic acute or chronic pancreatitis.
- Persistent diarrhea or malabsorption despite medical management.
- Peripheral neuropathy ≥ grade 2
- Impaired cardiac function or clinically significant cardiac diseases
- Subjects with diabetes on active treatment (for subjects treated on CC-223 containing arms only)
- Prior autologous stem cell transplant (ASCT) ≤ 3 months before first dose.
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting study drugs, whichever is shorter.
- Subjects who have undergone major surgery ≤ 2 weeks prior to starting study drugs.
- Women who are pregnant or breast feeding. Adults of reproductive potential not willing to employ two forms of birth control.
- Subjects with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV) infection.
- Subjects with treatment-related myelodysplastic syndrome.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Thomas Witzig, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office