A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Celgene
Study ID
NCT02343536
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral Azacitidine — DRUG
  • Rituximab — DRUG
  • cyclophosphamide — DRUG
  • Vincristine — DRUG
  • Prednisone — DRUG

Study Details

The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more) previously untreated DLBCL or Grade 3B FL. Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria.

Key Dates

Start date
Apr 29, 2015
Status verified
Aug 2020
Primary completion
Jan 29, 2020
Completion
Jan 29, 2020

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Azacitidine (CC-486) and R-CHOP
    Will examine four escalating dose-levels of CC- 486 (100 mg, 150 mg, 200 mg and 300 mg).
  • Active Comparator: R-CHOP
    R-CHOP, (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) \* rituximab, cyclophosphamide, doxorubicin, and vincristine are administered on Day 1; while prednisone is administered Days 1-5

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 1 year ]

Locations (7)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02117-
Washington University School of MedicineSt LouisMissouri63110-
Weill Cornell MedicineNew YorkNew York10065-
Rhode Island HospitalProvidenceRhode Island02903-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLUniversity of Chicago· Chicago, ILDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAWashington University School of Medicine· St Louis, MOWeill Cornell Medicine· New York, NY

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