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

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Celgene

Status and phase

Completed
Phase 2

Conditions

Lymphoma, Non-Hodgkin's

Treatments

Drug: lenalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413036
CC-5013-NHL-003

Details and patient eligibility

About

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

Enrollment

217 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

217 participants in 1 patient group

lenalidomide
Experimental group
Description:
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Treatment:
Drug: lenalidomide

Trial contacts and locations

53

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Data sourced from clinicaltrials.gov

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