A Phase 2 interventional study of Lenalidomide in Non-Hodgkins Lymphoma, sponsored by Celgene Corporation. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-21.
Sponsored by Celgene Corporation · Phase 2, Interventional, and Treatment
To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Celgene Corporation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any of the following laboratory abnormalities:
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.
Drug: Lenalidomide
Capsules for oral administration.
Also known as: CC-5013, Revlimid®
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.
Time frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Percentage of Participants With Tumor Control
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.
Time frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Duration of Response
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.
Time frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
Duration of Tumor Control
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.
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
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.
Time frame: 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)
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.
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.
| Milestone | Lenalidomide |
|---|---|
| Started | 50 |
| Received study drug | 49 |
| Completed 12 cycles of treatment | 12 |
| Completed | 0 |
| Not completed | 50 |
| Withdrew: Adverse event | 7 |
| Withdrew: Lack of therapeutic effect | 28 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 3 |
| Withdrew: Other - unspecified | 9 |
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 | Lenalidomide |
|---|---|
| Percentage of Participants With Response | 34.7 (21.7 to 49.6) |
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.
| percentage of participants | Lenalidomide |
|---|---|
| Percentage of Participants With Tumor Control | 59.2 (44.2 to 73.0) |
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.
| months | Lenalidomide |
|---|---|
| Duration of Response | 10.2 (4.0 to 16.3) |
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.
| months | Lenalidomide |
|---|---|
| Duration of Tumor Control | 6.0 (2.9 to 11.1) |
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.
| months | Lenalidomide |
|---|---|
| Progression-free Survival | 3.6 (2.0 to 6.3) |
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.
| participants | Lenalidomide |
|---|---|
| Any adverse event | 49 |
| Adverse event related to study drug | 42 |
| Grade 3-5 adverse event | 36 |
| Grade 3-5 adverse event related to study drug | 27 |
| Serious adverse event | 21 |
| Serious adverse event related to study drug | 6 |
| AE leading to discontinuation of study drug | 9 |
| Related AE leading to study drug discontinuation | 4 |
| AE leading to dose reduction or interruption | 28 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lenalidomide | — | 21/49 (42.9%) | 48/49 (98%) |
| Event | Lenalidomide |
|---|---|
| Non-Hodgkin's lymphoma NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/49 |
| PyrexiaGeneral disorders | 3/49 |
| Pneumonia NOSInfections and infestations | 3/49 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/49 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/49 |
| Dyspnea NOSRespiratory, thoracic and mediastinal disorders | 2/49 |
| Anemia NOSBlood and lymphatic system disorders | 1/49 |
| Coombs positive hemolytic anemiaBlood and lymphatic system disorders | 1/49 |
| Acute myocardial infarctionCardiac disorders | 1/49 |
| Cardiac failure congestiveCardiac disorders | 1/49 |
| Event | Lenalidomide |
|---|---|
| FatigueGeneral disorders | 19/49 |
| NeutropeniaBlood and lymphatic system disorders | 19/49 |
| ThrombocytopeniaBlood and lymphatic system disorders | 18/49 |
| ConstipationGastrointestinal disorders | 15/49 |
| Anaemia NOSBlood and lymphatic system disorders | 15/49 |
| Rash NOSSkin and subcutaneous tissue disorders | 13/49 |
| Diarrhoea NOSGastrointestinal disorders | 12/49 |
| Platelet Count DecreasedInvestigations | 11/49 |
| NauseaGastrointestinal disorders | 10/49 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/49 |
Intent to treat population includes all participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Lenalidomide |
|---|---|
| Mean | 64.8 ± 11.53 |
| Sex: Female, Male(Participants) | Lenalidomide |
|---|---|
| Female | 24 |
| Male | 25 |
| Race/Ethnicity, Customized(participants) | Lenalidomide |
|---|---|
| White | 36 |
| Black | 2 |
| Hispanic | 10 |
| Asian/Pacific Islander | 1 |
| Region of Enrollment(participants) | Lenalidomide |
|---|---|
| United States | 49 |
| Eastern Cooperative Oncology Group (ECOG) performance status(participants) | Lenalidomide |
|---|---|
| 0 | 20 |
| 1 | 23 |
| 2 | 5 |
| Missing | 1 |
| Non-Hodgkin's Lymphoma (NHL) Stage(participants) | Lenalidomide |
|---|---|
| Stage I | 1 |
| Stage II | 7 |
| Stage III | 9 |
| Stage IV | 32 |
| NHL histology(participants) | Lenalidomide |
|---|---|
| Follicular lymphoma grade 3 | 5 |
| Diffuse large B-cell lymphoma | 26 |
| Mantle cell lymphoma | 15 |
| Transformed | 3 |
| NHL Duration(years) | Lenalidomide |
|---|---|
| Mean | 4.0 ± 4.91 |
1 further baseline measures are reported on the registry.
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