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Status:

COMPLETED

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

Lead Sponsor:

Celgene

Conditions:

Lymphoma, Non-Hodgkin's

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2011

    Estimated Enrollment :

    217 Patients enrolled

    Trial Details

    Trial ID

    NCT00413036

    Start Date

    June 1 2006

    End Date

    May 1 2011

    Last Update

    March 1 2017

    Active Locations (53)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (53 locations)

    1

    Northwest Alabama Cancer Center, PC

    Muscle Shoals, Alabama, United States, 35661

    2

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259

    3

    Lalita Pandit, MD, Inc

    Fountain Valley, California, United States, 92708

    4

    Access Clinical Research

    Rancho Mirage, California, United States, 92270