Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 16, 2005
Results First Submitted Date	June 25, 2013
Results First Posted Date	September 2, 2013
Last Update Posted Date	January 21, 2016
Study Start Date ICMJE	August 2005
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 25, 2013)	Percentage of Participants With Response [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]; Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following: A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD); Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
Original Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	To determine the activity of lenalidiomide in relapsed or refractory aggressive non-Hodgkin’s lymphoma. Activity will be assessed by measuring the response rate, tumor control rate, duration of response and progression free survival.
Change History	Complete list of historical versions of study NCT00179660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 25, 2013)	Percentage of Participants With Tumor Control [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. SD was defined as a response less than a PR (see above) but not Progressive Disease (PD). PD was defined as ≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders. Appearance of any new lesion during or at the end of therapy.; Duration of Response [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.; Duration of Tumor Control [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.; Progression-free Survival [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.; Number of Participants With Adverse Events (AEs) [ Time Frame: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months. ]The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
Original Secondary Outcome Measures ICMJE; (submitted: September 13, 2005)	To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory aggressive NHL.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
Official Title ICMJE	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
Brief Summary	To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Non-Hodgkins Lymphoma
Intervention ICMJE	Drug: Lenalidomide; Capsules for oral administration.; Other Names: CC-5013; Revlimid®
Study Arms	Experimental: Lenalidomide; Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.; Intervention: Drug: Lenalidomide
Publications *	Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. doi: 10.1200/JCO.2007.15.3429. Epub 2008 Jul 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 25, 2013)	50
Original Enrollment ICMJE; (submitted: September 13, 2005)	40
Actual Study Completion Date	June 2008
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Understand and voluntarily sign an informed consent form.; Age greater than or equal to 18 years at the time of signing the informed consent form; Able to adhere to the study visit schedule and other protocol requirements; Biopsy-proven non-Hodgkin's lymphoma; Aggressive lymphoma, the following histologies are acceptable: Follicular center lymphoma, grade 3, Diffuse large cell, Mantle cell, Transformed; Relapsed or refractory to previous therapy for lymphoma. Patients must have received at least one prior treatment regimen such as radiation, immunotherapy, chemotherapy, or radioimmunotherapy, and be ineligible or unwilling to undergo an autologous stem cell transplant. There is no limit on the number of prior therapies.; Patients must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.; Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.; Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. Exclusion Criteria: Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <1,500 cells/mm^3 (1.5 x 10^9/L) Platelet count <100,000/mm^3 (100 x 10^9/L) Serum creatinine >2.5 mg/dL (221 mmol/L) Serum aspartate transaminase (AST) or alanine transaminase (ALT) >5.0 x upper limit of normal (ULN) Serum total bilirubin >2.0 mg/dL (34 mmol/L); Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study; All patients with central nervous system (CNS) disease with the exception of those patients whose CNS disease has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture, computed tomography (CT) scan or magnetic resonance imaging (MRI), for at least 6 months.; Prior history of malignancies other than non-Hodgkin's lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or equal to 1 year; Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form; Known positive for human immunodeficiency virus (HIV); Pregnant or lactating females; Prior > or equal to grade 3 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) allergic reaction/hypersensitivity to thalidomide; Prior > or equal to grade 3 NCI CTCAE rash or any desquamating (blistering) rash while taking thalidomide; Prior use of lenalidomide; Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1 of study drug therapy; Known active Hepatitis C
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00179660
Other Study ID Numbers ICMJE	CC-5013-NHL-002
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Celgene ( Celgene Corporation )
Study Sponsor ICMJE	Celgene Corporation
Collaborators ICMJE	Prologue Research International
Investigators ICMJE	Not Provided
PRS Account	Celgene
Verification Date	December 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP