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

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ClinicalTrials.gov Identifier: NCT00413036
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 11, 2013
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin's Drug: lenalidomide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: lenalidomide
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Drug: lenalidomide
once daily oral capsule
Other Name: Revlimid



Primary Outcome Measures :
  1. Participants Categorized by Best Response as Determined by Central Review [ Time Frame: Up to 1459 days ]

    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 :
  1. Duration of Response as Determined by Central Review [ Time Frame: Up to 1459 days ]

    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.


  2. Time to Progression as Determined by Central Review [ Time Frame: Up to 1459 days ]

    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.

  3. Progression-free Survival as Determined by Central Review [ Time Frame: Up to 1459 days ]

    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.

  4. Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review [ Time Frame: Up to 1459 days ]

    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413036


  Show 53 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Lei Zhang, MD Celgene Corporation

Publications of Results:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00413036     History of Changes
Other Study ID Numbers: CC-5013-NHL-003
First Posted: December 19, 2006    Key Record Dates
Results First Posted: April 11, 2013
Last Update Posted: March 1, 2017
Last Verified: January 2017

Keywords provided by Celgene:
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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents