Clinical trial NCT00413036: A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin's
Keywords: Celgene
Revlimid
CC-5013
Non-hodgkin's lymphoma
Lenalidomide
CC5013
NHL
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop


Eligibility criteria: Key Inclusion criteria

* Biopsy proven aggressive non-hodgkin's lymphoma

  * Follicular center lymphoma Grade 3.
  * Diffuse large B-cell lymphoma.
  * Mantle cell lymphoma.
  * Transformed lymphoma.
* Relapsed or refractory to previous therapy for lymphoma
* At least one prior combination chemotherapy regime
* Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
* Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
* Willing to follow the pregnancy precautions

Key Exclusion criteria

* Any of the following laboratory abnormalities.

  * Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5\*10\^9/L).
  * Platelet count \< 60,000/mm\^3 (60\*10\^9/L).
  * Calculated creatinine clearance of \<50mL/min
  * Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
  * Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)/conjugated bilirubin \>0.8mg/dL.
* Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
* History of active Central Nervous System (CNS) lymphoma within the previous 6 months
* History of other malignancies within the past year
* Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Primary outcomes:
measure: Participants Categorized by Best Response as Determined by Central Review
timeFrame: Up to 1459 days
Secondary outcomes:
measure: Duration of Response as Determined by Central Review
timeFrame: Up to 1459 days
measure: Time to Progression as Determined by Central Review
timeFrame: Up to 1459 days
measure: Progression-free Survival as Determined by Central Review
timeFrame: Up to 1459 days
measure: Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
timeFrame: Up to 1459 days
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, PC
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Fountain Valley
country: United States
facility: Lalita Pandit, MD, Inc
state: California
city: Rancho Mirage
country: United States
facility: Access Clinical Research
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates
state: Florida
city: Miami
country: United States
facility: Sylvester Cancer Center/ Univeristy of Miami
state: Florida
city: Rockledge
country: United States
facility: Hematology Oncology Associates of Central Brevard
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: New Albany
country: United States
facility: Cancer Care Center, Inc.
state: Indiana
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Southgate
country: United States
facility: Michigan Hematology and Oncology Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Cherry Hill
country: United States
facility: Center for Cancer and Hematologic Disease
state: New Jersey
city: Bronx
country: United States
facility: Our Lady of Mercy Cancer Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Pittsburg
country: United States
facility: HIllman Cancer Center -UPMC
state: Pennsylvania
city: Spartanburg
country: United States
facility: Palmetto Hematology Oncology
state: South Carolina
city: Collierville
country: United States
facility: Family Cancer Center
state: Tennessee
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
city: Créteil
country: France
facility: Service d'Hématologie Clinique
city: Dijon
country: France
facility: Clinical Haematology Department
city: Marseille
country: France
facility: Institute Paoli-Calmettes Départmentd 'Hématologie
city: Montpellier
country: France
facility: CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Louis Service d'Hémato-Oncologie
city: Pessac
country: France
facility: Hopital du Haut-Lévèque
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud, Hematologie Clinique
city: Rouen
country: France
facility: Department d'Hématologie Centre Henri Becquerel
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Goettingen
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Bologna
country: Italy
facility: Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
city: Genova
country: Italy
facility: O.U. di Clinica Ematologica
city: Pavia
country: Italy
facility: Ospedale Policlinico S. Matteo
city: Roma
country: Italy
facility: Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial, Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre,
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria, Servicio de oncologia
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Pontevedra
country: Spain
facility: Complexo Hospitalario de Pontevedra Oncology Department
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
city: Valencia
country: Spain
facility: Research Site
city: Southampton
country: United Kingdom
facility: Somers Cancer Research Building
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust London and Surrey
city: Withington
country: United Kingdom
facility: Medical Oncology, Christie Hospital NHS Trust
Study officials:
affiliation: Celgene Corporation
name: Lei Zhang, MD
role: STUDY_DIRECTOR
References:
citation: Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.
citation: Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12.