- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03930953
Recruitment Status Recruiting
First Posted April 29, 2019
Last update posted June 11, 2020
CC-99282-NHL-001 study is a Phase I dose escalation and expansion clinical study of CC-99282 administered alone and in combination with rituximab in subjects with relapsed or refractory non-hodgkin Lymphomas (R/R NHL).
Subjects with R/R NHL who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in R/R DLBCL and/or R/R FL subjects to determine the MTD of CC-99282 as monotherapy. The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with rituximab in subjects with R/R DLBCL and R/R FL.
|Experimental: Administration of CC-99282
Escalating doses of CC-99282 administered orally once daily on intermittent schedules up to 2 years.
|Experimental: CC-99282 + rituximab
CC-99282 administered orally once daily on intermittent schedule with rituximab intravenously (IV) 375 mg/m2 weekly in Cycle 1, every 28 days in C2-6, then every 8 weeks through 2 years.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
2. Subject has a history of NHL with relapsed or refractory disease
3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
4. Subjects 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 pegfilgastrim)
2. Hemoglobin (Hgb) ≥ 8 g/dL
3. Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days
4. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
5. AST/SGOT and ALT/SGPT ≤ 2.5X ULN
6. Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault
5. Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)
The presence of any of the following will exclude a subject from enrollment:
1. Subject has life expectancy ≤ 2 months.
2. Subject has received prior systemic anti-cancer treatment (approved or
investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is
3. Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects
in Part B).
4. Persistent diarrhea or malabsorption≥ Grade 2 , despite medical management
5. Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg,
prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or
subjects with clinically significant graft-versus-host disease (GVHD).
6. Subject had prior autologous SCT ≤ 3 months prior to starting CC 99282. If subject had
prior autologous SCT > 3 months prior to the start of CC-99282, any treatment-related
toxicity is unresolved (grade > 1).
7. Subject had prior allogeneic SCT with either standard or reduced intensity
conditioning ≤ 6 months prior to starting CC-99282. If subject had prior allogenic SCT
> 6 months prior to the start of CC-99282, any treatment-related toxicity is
unresolved (grade > 1).
8. Impaired cardiac function or clinically significant cardiac disease
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 firstname.lastname@example.org
United States, Florida
H Lee Moffitt Cancer Center
United States, Missouri
United States, New Jersey
Hackensack University Medical Center
United States, Texas
MD Anderson Cancer Center
Princess Margaret Cancer Centre
Centre Hospitalier Lyon-Sud
Azienda Ospedaliera Papa Giovanni XXIII
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
Vall d´Hebron University Hospital
Fundacion Jimenez Daaz
Study Director: Poliana Patah, MD, PhD Bristol-Myers Squibb