A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin's Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413036
• Other study ID #: CC-5013-NHL-003
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2006
• Last updated: March 6, 2013
• Start date: June 2006
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's

Intervention

Drug:
• lenalidomide
once daily oral capsule

Locations

Country	Name	City	State
Canada	London Health Science Center	London	Ontario
Canada	Saskatoon Cancer Center	Saskatoon	Saskatchewan
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto
France	Service d'Hématologie Clinique	Créteil
France	Clinical Haematology Department	Dijon
France	Institute Paoli-Calmettes Départmentd 'Hématologie	Marseille
France	CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale	Montpellier
France	Hopital Saint Louis Service d'Hémato-Oncologie	Paris
France	Hopital du Haut-Lévèque	Pessac
France	Centre Hospitalier Lyon Sud, Hematologie Clinique	Pierre Bénite
France	Department d'Hématologie Centre Henri Becquerel	Rouen
Germany	Research Site	Berlin
Germany	Universitaetsklinikum Essen	Essen
Germany	Research Site	Goettingen
Germany	Research Site	Heidelberg
Germany	Research Site	Homburg
Germany	Research Site	Koeln
Italy	Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"	Bologna
Italy	O.U. di Clinica Ematologica	Genova
Italy	Ospedale Policlinico S. Matteo	Pavia
Italy	Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina	Roma
Italy	Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),	Torino
Spain	Hospital Clinic I Provincial, Servicio de Hematologia	Barcelona
Spain	Hospital Clinicio San Carlos, Servivio de Hematologia Clinica	Madrid
Spain	Hospital Universitario 12 de Octubre,	Madrid
Spain	Hospital Universitario Virgen de la Victoria, Servicio de oncologia	Malaga
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Complexo Hospitalario de Pontevedra Oncology Department	Pontevedra
Spain	Hospital Clinico Universitario de Salamanca, Servicio de Hematologia	Salamanca
Spain	Research Site	Valencia
United Kingdom	Somers Cancer Research Building	Southampton
United Kingdom	Royal Marsden Hospital NHS Foundation Trust London and Surrey	Surrey
United Kingdom	Medical Oncology, Christie Hospital NHS Trust	Withington
United States	Ochsner Clinic Foundation	Baton Rouge	Louisiana
United States	Our Lady of Mercy Cancer Center	Bronx	New York
United States	Pasco Hernando Oncology Associates	Brooksville	Florida
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	Family Cancer Center	Collierville	Tennessee
United States	Lalita Pandit, MD, Inc	Fountain Valley	California
United States	Sylvester Cancer Center/ Univeristy of Miami	Miami	Florida
United States	Northwest Alabama Cancer Center, PC	Muscle Shoals	Alabama
United States	Cancer Care Center, Inc.	New Albany	Indiana
United States	University of Nebraska	Omaha	Nebraska
United States	HIllman Cancer Center -UPMC	Pittsburg	Pennsylvania
United States	Access Clinical Research	Rancho Mirage	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Hematology Oncology Associates of Central Brevard	Rockledge	Florida
United States	Kaiser Permanente Medical Group	San Diego	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Michigan Hematology and Oncology Institute	Southgate	Michigan
United States	Palmetto Hematology Oncology	Spartanburg	South Carolina
United States	Palm Beach Cancer Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Categorized by Best Response as Determined by Central Review	Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.; Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.; Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.; Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.; Stable Disease(SD): Less than PR, but not progressive disease.; Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.	Up to 1459 days	No
Secondary	Duration of Response as Determined by Central Review	Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.; For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.	Up to 1459 days	No
Secondary	Time to Progression as Determined by Central Review	Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.; Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.; Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.	Up to 1459 days	No
Secondary	Progression-free Survival as Determined by Central Review	Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.; Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.; Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.	Up to 1459 days	No
Secondary	Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review	Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.; Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.; Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.; Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.; Stable Disease(SD): Less than PR, but not progressive disease.	Up to 1459 days	No