Loading clinical trials...

Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT02031419•Celgene

View on ClinicalTrials.gov

Summary

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

Detailed Description

Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy. In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.
+5 more criteria

Locations (16)

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

Key Dates

Start Date

December 18, 2013

Primary Completion Date

December 12, 2023

Completion Date

December 12, 2023

Last Updated

January 18, 2024

Enrollment

174

ACTUAL participants

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

CC-122

DRUG

CC-223

DRUG

Rituximab

DRUG

CC-122

DRUG

CC-292

DRUG

Rituximab

DRUG

CC-223

DRUG

CC-292

DRUG

Rituximab

DRUG

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

NCT06528301

Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis

NCT03293173

Lymphoma, Large B-Cell, Diffuse

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis

A Trial Comparing the Two High-dose Chemotherapies BeEAM and BEAM Given Before Autologous Stem Cell Transplantation (ASCT) in Lymphoma Patients (BEB-trial)

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Fatigue Reduction Diet in Lymphoma Survivors

Safety Study of SEA-CD40 in Cancer Patients