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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
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's

Thank you

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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Lei Zhang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-NHL-003

NCT ID:

NCT00413036

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Kaiser Permanente Medical GroupLos Angeles, California  90027
Center for Cancer And Hematologic DiseaseCherry Hill, New Jersey  08046
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Family Cancer CenterCollierville, Tennessee  38017
Pasco Hernando Oncology AssociatesNew Port Richey, Florida  34652
University of NebraskaOmaha, Nebraska  68198
Northwest Alabama Cancer Center, PCFlorence, Alabama  35630
Hematology Oncology Associates of Central BrevardRockledge, Florida  32955
Cancer Care Center, Inc.New Albany, Indiana  47150
Lalita Pandit, MD, IncFountain Valley, California  92708
Michigan Hematology and Oncology InstituteSouthgate, Michigan  48195
Palmetto Hematology OncologySpartanburg, South Carolina  29303
Access Clinical ResearchRancho Mirage, California  92270
Sylvester Cancer Center/ Univeristy of MiamiMiami, Florida  33136
Our Lady of Mercy Cancer CenterBronx, New York  10466
HIllman Cancer Center -UPMCPittsburg, Pennsylvania  15232