Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue for up to 52 weeks or until disease progression; participants who achieve a complete response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Participants will be followed for progression free survival following discontinuation from the treatment phase
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma|
- Percentage of Participants With Response [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ] [ Designated as safety issue: No ]
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 4.4 months with a maximum of 32 months ] [ Designated as safety issue: No ]
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.
- The Duration of Response [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ] [ Designated as safety issue: No ]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.
- Progression Free Survival (PFS) [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ] [ Designated as safety issue: No ]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 13.8 months. ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||August 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
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
Other Name: CC-5013; Revlimid®
Participants who qualified for enrollment into the study entered the treatment phase and received single-agent lenalidomide 25 mg once daily on Days 1 to 21 of every 28-day cycle. The treatment phase began on Day 1 of Cycle 1. Study visits were scheduled to occur every 28 days to coincide with the beginning of a new cycle. The start date of a new cycle was delayed if adverse events (AEs) occurred, in which case the visit date for the start of the following cycle was scheduled 28 days after the actual start date of the delayed cycle. Efficacy and safety assessments, including complete blood counts (CBCs) were performed at least every 2 weeks during Cycles 1 to 4 of the treatment phase. Participants continued in the treatment phase of the study for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|Alta Bates Cancer Center|
|Berkeley, California, United States, 94704|
|Pacific Coast Hematology/Oncology Medical Group, Onc.|
|Fountain Valley, California, United States, 92708|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|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, Ohio|
|Signal Point Hematology/Oncology|
|Middletown, Ohio, United States, 45042|
|United States, Washington|
|Swedish Cancer Institute|
|Seattle, Washington, United States, 98104|
|United States, Wisconsin|
|Gunderson Clinic, Ltd.|
|La Crosse, Wisconsin, United States, 54601|
|Canada, British Columbia|
|BC Community Oncology Trialist|
|Burnaby, British Columbia, Canada, V5H 4K7|
|BC Community Oncology|
|North Vancouver, British Columbia, Canada, V7L 2P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 5W9|
|University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Director:||Robert Knight, MD||Celgene Corporation|