Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

Stopped early · Phase 1

Conditions studied: Lymphoma, Large B-Cell, Diffuse

In brief

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) and Follicular Lymphoma

Key facts

Study ID

NCT02031419

Run by

Celgene

People needed

174

Starts

2013-12-18

Expected to finish

2023-12-12

Last updated by the study team

2024-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, 18 years or older, with histologically or cytologically-confirmed either:
• Chemo-refractory DLBCL (including transformed low grade lymphoma)
• Lenalidomide naïve; relapsed or refractory CD20-positive follicular lymphoma (Grade 1, 2, or 3a) following at least one prior standard systemic treatment regimen including systemic chemo-, immune-; or chemo-immunotherapy and at least one prior line of salvage therapy with no prior exposure to lenalidomide, or double-refractory FL participants with no prior exposure to lenalidomide (FL-1 cohort)
• Lenalidomide exposed: relapsed or refractory CD20-positive follicular lymphoma (Grade 1, 2, or 3a) previously treated with at least two cycles of lenalidomide-containing regimen (FL-2 cohort), either as a single agent or in combination
• At least one site of measurable disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Participants 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.
• 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
• Participants must have the following laboratory values:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if participants received pegfilgrastim).
• Males enrolled into treatment arms receiving CC-122 must: Agree to abstain from donating sperm while taking IP and for at least 95 days following discontinuation of IP

You may not qualify if…

• 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
• Participants with diabetes on active treatment (for participants 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.
• Participants 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.
• Participants with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV) infection.
• Participants with treatment-related myelodysplastic syndrome.
• History of concurrent second cancers requiring active, ongoing systemic treatment.
• Prior treatment with a dual mTORC1/mTORC2 inhibitor (CC-223 arms only) or BTK inhibitor (PCI-32765) (CC-292 arms only). [Prior treatment with rapamycin analogues, PI3K or AKT inhibitors, lenalidomide and rituximab are allowed].

Where it is running

• Stanford Cancer Center — Stanford, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Local Institution - 005 — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Local Institution - 001 — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Local Institution - 007 — Madison, Wisconsin, United States
• Local Institution - 402 — Edmonton, Alberta, Canada
• Local Institution - 400 — Toronto, Ontario, Canada
• Local Institution - 102 — Bordeaux, France
• Local Institution - 101 — Lyon, France
• Local Institution - 100 — Villejuif, France
• Local Institution - 202 — Milan, Italy
• Local Institution - 200 — Rozzano (MI), Italy
• Local Institution - 201 — Turin, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.