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A Phase 2, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid (R)) in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma

Thank you

Trial Information

A Phase 2, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid (R)) in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial


Inclusion Criteria:



- Biopsy proven mantle cell lymphoma

- Patients must have documents relapsed, refractory or PD after treatment with
bortezomib

- Must have measureable disease on cross sectional imaging by CT

- Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2

- Willing to follow pregnancy precautions

Exclusion Criteria:

- Any of the following laboratory abnormalities

- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)

- Platelet count < 60,000/mm3 (60 x 109/L)

- Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT)
or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x
upper limit of normal (ULN), except in patients with documented liver
involvement by lymphoma.

- Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and
documented liver involvement by lymphoma.

- Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min

- Patients who are candidates for high dose chemotherapy/allogeneic stem cell
transplant are not eligible

- History of active central nervous system (CNS) lymphoma within the previous 3
months

- Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis

- Prior history of malignancies, other than MCL, unless the patient has been free
of the disease for ≥ 3 years

- 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:

Tumor Response and Duration of Response(Radiological Assessments as defined by IWLRC 1999)

Outcome Time Frame:

After all subjects complete 6 cycles of study drug

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-MCL-001

NCT ID:

NCT00737529

Start Date:

October 2008

Completion Date:

February 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • CC-5013
  • Revlimid
  • Lenalidomide
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Mayo Clinic Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Avera Cancer Institute Sioux Falls, South Dakota  57105
Loyola University Medical Center Maywood, Illinois  60153
Loma Linda University Medical Center Loma Linda, California  92354
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Hackensack University Medical Center Hackensack, New Jersey  07601
Broward General Medical Center Fort Lauderdale, Florida  33316
Washington University Siteman Cancer Center Saint Louis, Missouri  63110
Presbyterian Hospital Charlotte, North Carolina  28233-3549
University of Virginia Charlottesville, Virginia  22908
Northwestern University Chicago, Illinois  60611
Tower Cancer Research Foundation Beverly Hills, California  90211
UCSD Moores Cancer Center La Jolla, California  93093
Tufts Medical Center Boston, Massachusetts  02111
Pasco Hernando Oncology Associates New Port Richey, Florida  34652
Karmanos Cancer Institute Detroit, Michigan  48201
NYU School of Medicine New York, New York  10016
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Temple University School of Medicine Philadelphia, Pennsylvania  19140
South Carolina Cancer Specialists Hilton Head Island, South Carolina  29925
University of Massachusetts Medical Center Worcester, Massachusetts  01605
Boca Raton Community Hospital, Inc. - Center for Hematology-Oncology Boca Raton, Florida  33486
MD Anderson Cancer Center Orlando, Orlando Regional Healthcare Orlando, Florida  32806
Lake County Oncology and Hematology The Villages, Florida  32159
Sinai Hospital - Alvin & Lois Lapidus Cancer Institute Baltimore, Maryland  21215
Univeristy of Nebraska Medical Center Omaha, Nebraska  68198
University of Rochester Cancer Center, James P. Wilmot Cancer Center Rochester, New York  14642
UPMC, Hillman Cancer Center Pittsburgh, Pennsylvania  15232
University of Tennessee, Boston Baskin Cancer Group, PLC Memphis, Tennessee  38104