Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Celgene
Study ID
NCT02285062
Phase
PHASE3
Status
Completed

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • lenalidomide — DRUG
  • Placebo — DRUG
  • Rituximab — DRUG
  • Cyclophosphamide — DRUG
  • Doxorubicin — DRUG
  • prednisone — DRUG
  • vincristine — DRUG

Study Details

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Key Dates

Start date
Feb 17, 2015
Status verified
May 2023
Primary completion
Mar 15, 2019
Completion
Jul 28, 2022

Study Design

Enrollment
570 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R2-CHOP
    Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
  • Active Comparator: R-CHOP
    Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)

Primary Outcome Measure

Kaplan-Meier Estimate of Progression Free Survival (PFS) [ Time Frame: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months ]

Locations (22)

FacilityCityStateZIPSite coordinators
Local Institution - 177FayettevilleArkansas72703-
Local Institution - 136OrangeCalifornia92868-
Local Institution - 127SacramentoCalifornia95817-
Local Institution - 169New HavenConnecticut06510-
Local Institution - 128HollywoodFlorida33021-
McFarland ClinicAmesIowa50010-3014-
Siouxland Hematology-Oncology Associates, LLPSioux CityIowa51101-1733-
Local Institution - 143FairwayKansas66205-
Local Institution - 158ShreveportLouisiana71103-
Center For Cancer And Blood DisordersBethesdaMaryland20817-
Local Institution - 101MinneapolisMinnesota55416-
Local Institution - 138MinneapolisMinnesota55455-
Local Institution - 112RochesterMinnesota55905-
Local Institution - 103DurhamNorth Carolina27710-
Local Institution - 161PhiladelphiaPennsylvania19111-
Local Institution - 151DallasTexas75390-9068-
Local Institution - 951DallasTexas75235-
Local Institution - 146Salt Lake CityUtah84106-
Local Institution - 905EdmondsWashington98026-
Local Institution - 903IssaquahWashington98029-
Local Institution - 162SeattleWashington98104-
Local Institution - 904SeattleWashington98107-

Find similar trials in Fayetteville, AR

By research site
Local Institution - 177· Fayetteville, ARLocal Institution - 136· Orange, CALocal Institution - 127· Sacramento, CALocal Institution - 169· New Haven, CTLocal Institution - 128· Hollywood, FLMcFarland Clinic· Ames, IA

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