Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Aggression

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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.

To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.

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

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.

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 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.

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 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.

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.

Prologue Research International

Celgene Corporation

Age, Continuous

Sex: Female, Male

White

Black

Hispanic

Asian/Pacific Islander

Race/Ethnicity, Customized

United States

Region of Enrollment

Missing

0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self care but unable to work.

Eastern Cooperative Oncology Group (ECOG) performance status

Stage I

Stage II

Stage III

Stage IV

I: The lymphoma is in only 1 lymph node area or 1 area of a single organ outside the lymph system.

II: The lymphoma is in 2 or more groups of lymph nodes on the same side of the diaphragm, or extends from a single group of node(s) into a nearby organ.

III: The lymphoma is found in lymph node areas on both sides of the diaphragm, or may also have spread into an area or organ next to the lymph nodes, the spleen, or both.

IV: The lymphoma has spread outside the lymph system into an organ that is not next to an involved node or has spread to bone marrow, liver, brain, spinal cord or the pleura.

Non-Hodgkin's Lymphoma (NHL) Stage

Follicular lymphoma grade 3

Diffuse large B-cell lymphoma

Mantle cell lymphoma

Transformed

NHL histology

NHL Duration

Low (0 to 1)

Low/Intermediate (2)

High/Intermediate (3)

High (4 to 5)

A clinical tool to aid in predicting the prognosis of patients with aggressive NHL. One point is assigned for each of the following risk factors:

* Age greater than 60 years
* Stage III or IV disease
* Elevated serum lactate dehydrogenase
* ECOG performance status of 2, 3, or 4 -\> 1 extranodal site

The sum of the points allotted correlates with the following risk groups:

Low risk (0-1 points): 5-year survival of 73% Low-intermediate risk (2 points): 5-year survival of 51% High-intermediate risk (3 points): 5-year survival of 43% High risk (4-5 points): 5-year survival of 26%

International Prognostic Index (IPI)

Intent to treat population includes all participants who received at least 1 dose of study drug.

Associate Director, Clinical Trials Disclosure

Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.

Percentage of Participants With Response

Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.

Percentage of Participants With Tumor Control

Intent to treat population with a response = CR, CRu or PR.

Duration of Response

Intent to treat population with tumor control (CR, CRu, PR or SD).

Duration of Tumor Control

Progression-free Survival

Any adverse event

Adverse event related to study drug

Grade 3-5 adverse event

Grade 3-5 adverse event related to study drug

Serious adverse event

Serious adverse event related to study drug

AE leading to discontinuation of study drug

Related AE leading to study drug discontinuation

AE leading to dose reduction or interruption

Safety Population, which includes all participants who received at least one dose of study drug.

Number of Participants With Adverse Events (AEs)

Overall Study

Spots Global Cancer Trial Database for Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial