Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Official Title

A Phase I, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

Details

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.

Keywords

Lymphoma, Non-Hodgkin Non-Hodgkin Lymphomas Safety Efficacy CC-99282 Rituximab Relapsed Refractory Lymphoma Administration of CC-99282 CC-99282 + rituximab

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  5. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim)
  6. Hemoglobin (Hgb) ≥ 8 g/dL
  7. Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days
  8. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
  9. AST/SGOT and ALT/SGPT ≤ 2.5X ULN
  10. Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation.
  11. Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)

You CAN'T join if...

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 shorter.
  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

Locations

  • University of California, Irvine not yet accepting patients
    Orange California 92848 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03930953
Phase
Phase 1
Study Type
Interventional
Last Updated