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

Trial ID or NCT#

NCT02031419

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Men and women, 18 years or older, with histologically or cytologically-confirmed either:
    1. 1. Chemo-refractory DLBCL (including transformed low grade lymphoma) 2. 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) 3. 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:
      1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if participants received pegfilgrastim).
  2. * 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
Exclusion Criteria:
  1. * 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). \[Prior treatment with rapamycin analogues, PI3K or AKT inhibitors, lenalidomide and rituximab are allowed\].
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Investigator(s)

Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma
Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov