©2022 Stanford Medicine
Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma
Not Recruiting
Trial ID: NCT02031419
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
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Hans-Christoph Becker, MD, FSABI, FSCCT
Clinical Professor, Radiology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Eligibility
Inclusion Criteria:
- Men and women, 18 years or older, with histologically or cytologically-confirmed
either:
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:
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
Exclusion Criteria:
- 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].
Intervention(s):
drug: CC-122
drug: CC-223
drug: Rituximab
drug: CC-122
drug: CC-292
drug: Rituximab
drug: CC-223
drug: CC-292
drug: Rituximab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061