Clinical trial · Interventional
Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma
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
NCT02031419CI-TRIAL-00073088terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Replaced with another clinical trial.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-122 | Drug | — | UNRESOLVED |
| CC-223 | Drug | Onatasertib | ALIAS |
| CC-292 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- CC-122 + CC-223 +/- rituximab
- description
- CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-223 administered orally once daily at 20mg or 30 mg with or without Rituximab administered by IV once every 28 days
- interventionNames
- Drug: CC-122
- Drug: CC-223
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- CC-122 + CC-292 +/- rituximab
- description
- CC-122 administered orally once daily at 2mg or 3 mg in combination with CC-292 administered orally twice daily at 500 mg with or without Rituximab administered by IV once every 28 days
- interventionNames
- Drug: CC-122
- Drug: CC-292
- Drug: Rituximab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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). \[Prior treatment with rapamycin analogues, PI3K or AKT inhibitors, lenalidomide and rituximab are allowed\].
References
Publications (0)
Data not yet available
No reference posted for this study.