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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

Phase 2
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin's

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Trial Information

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

Inclusion 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants Categorized by Best Response as Determined by Central Review

Outcome Description:

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.

Outcome Time Frame:

Up to 1459 days

Safety Issue:


Principal Investigator

Lei Zhang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

May 2011

Related Keywords:

  • Lymphoma, Non-Hodgkin's
  • Celgene
  • Revlimid
  • CC-5013
  • Non-hodgkin's lymphoma
  • Lenalidomide
  • CC5013
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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