Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
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
1 other identifier
interventional
50
1 country
8
Brief Summary
To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2005
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
September 2, 2013
CompletedJanuary 21, 2016
December 1, 2015
2.8 years
September 13, 2005
June 25, 2013
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Response
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.
From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Secondary Outcomes (5)
Percentage of Participants With Tumor Control
From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Duration of Response
From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Duration of Tumor Control
From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Progression-free Survival
From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Number of Participants With Adverse Events (AEs)
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.
Study Arms (1)
Lenalidomide
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgene Corporationlead
- Prologue Research Internationalcollaborator
Study Sites (8)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Pacific Coast Hematology/Oncology Medical Group, Onc.
Fountain Valley, California, 92708, United States
UC David Cancer Center
Sacramento, California, 95817, United States
Sylvester Cancer CenterUniversity Of Miami
Miami, Florida, 33136, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska
Omaha, Nebraska, 68198-6805, United States
New York Medical Center, MBCCOP
The Bronx, New York, 10466, United States
Gunderson Clinic, Ltd
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
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.
PMID: 18606983RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trials Disclosure
- Organization
- Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
August 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 21, 2016
Results First Posted
September 2, 2013
Record last verified: 2015-12