Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
|ClinicalTrials.gov Identifier: NCT00179660|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 2, 2013
Last Update Posted : January 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkins Lymphoma||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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.
Capsules for oral administration.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179660
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|Pacific Coast Hematology/Oncology Medical Group, Onc.|
|Fountain Valley, California, United States, 92708|
|UC David Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Florida|
|Sylvester Cancer CenterUniversity Of Miami|
|Miami, Florida, United States, 33136|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Nebraska|
|University of Nebraska|
|Omaha, Nebraska, United States, 68198-6805|
|United States, New York|
|New York Medical Center, MBCCOP|
|Bronx, New York, United States, 10466|
|United States, Wisconsin|
|Gunderson Clinic, Ltd|
|La Crosse, Wisconsin, United States, 54601|