A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma - Full Text View

Purpose

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin's	Drug: lenalidomide	Phase 2

Study Type:	Interventional
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 Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Participants Categorized by Best Response as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.
- Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
- Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
- Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
- Stable Disease(SD): Less than PR, but not progressive disease.
- Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

Secondary Outcome Measures:

Duration of Response as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]
Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.
Time to Progression as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
- Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
Progression-free Survival as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
- Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.
- Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
- Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
- Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
- Stable Disease(SD): Less than PR, but not progressive disease.

Enrollment:	217
Study Start Date:	June 2006
Study Completion Date:	May 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lenalidomide 25 mg oral lenalidomide once daily on Days 1-21 every 28 days	Drug: lenalidomide once daily oral capsule Other Name: Revlimid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion criteria

Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
Relapsed or refractory to previous therapy for lymphoma
At least one prior combination chemotherapy regime
Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
Willing to follow the pregnancy precautions

Key Exclusion criteria

Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).
- Platelet count < 60,000/mm^3 (60*10^9/L).
- Calculated creatinine clearance of <50mL/min
- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active Central Nervous System (CNS) lymphoma within the previous 6 months
History of other malignancies within the past year
Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413036

Show 53 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Lei Zhang, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036 History of Changes
Other Study ID Numbers:	CC-5013-NHL-003
Study First Received:	December 18, 2006
Results First Received:	January 9, 2013
Last Updated:	March 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Celgene
Revlimid
CC-5013
Non-hodgkin's lymphoma

Lenalidomide
CC5013
NHL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013