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

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