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LYMPHOMA: NHL; DLBCL; Phase 1; \"CC-122-DLBCL-001\"

A phase 1b, multi-center, open-lable study of novel combinations of CC-122, CC-223, CC-292 and rituximab in diffuse large B-cell lymphoma

Title
Celgene CC-122-DLBCL-001
Study Title

A phase 1b, multi-center, open-lable study of novel combinations of CC-122, CC-223, CC-292 and rituximab in diffuse large B-cell lymphoma

Site Link
Malignancy
Lymphoma, Diffuse Large B-cell lymphoma, DLBCL
Stage
Disease Setting
Relapsed/Refractory
Line Of Therapy
>2nd line
Investigational Agent
CC-122 and/or CC-223 and/or CC-292
Drug Class
anti-CRBN (CC-122); mTOR kinase inhibitor (CC-223); BTK ihibitor (CC-292)
PI
Daruka Mahadevan, MD, PhD
Sponsor
Celgene Corporation
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

Biopsy proven DLBCL
Relapsed or refractory to standard treatment
ECOG PS 0-1
Measurable disease
ANC>1.5, plts>50
No CNS involvement
No impared cardiac function
No active tx for diabetes (if on CC-223 arm only)
No prior allo HCT
No auto HCT within 3 months
No systemic anti-cancer tx within 4 weeks_

Objective

Primary- safety (DLT); Secondary- ORR, PK

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Dosing Frequency

CC122- 2mg or 3 mg PO daily; CC223-20mg or 30mg PO daily; CC292- 500mg PO bid; Rituxan- 375mg/m2 q28 days

Control Agents
Rituximab
Study Protocol
Randomized
No
X