Know Cancer

or
forgot password

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 ClinicRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Avera Cancer InstituteSioux Falls, South Dakota  57105
Loyola University Medical CenterMaywood, Illinois  60153
Loma Linda University Medical CenterLoma Linda, California  92354
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Broward General Medical CenterFort Lauderdale, Florida  33316
Washington University Siteman Cancer CenterSaint Louis, Missouri  63110
Presbyterian HospitalCharlotte, North Carolina  28233-3549
University of VirginiaCharlottesville, Virginia  22908
Northwestern UniversityChicago, Illinois  60611
Tower Cancer Research FoundationBeverly Hills, California  90211
UCSD Moores Cancer CenterLa Jolla, California  93093
Tufts Medical CenterBoston, Massachusetts  02111
Pasco Hernando Oncology AssociatesNew Port Richey, Florida  34652
Karmanos Cancer InstituteDetroit, Michigan  48201
NYU School of MedicineNew York, New York  10016
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Temple University School of MedicinePhiladelphia, Pennsylvania  19140
South Carolina Cancer SpecialistsHilton Head Island, South Carolina  29925
University of Massachusetts Medical CenterWorcester, Massachusetts  01605
Boca Raton Community Hospital, Inc. - Center for Hematology-OncologyBoca Raton, Florida  33486
MD Anderson Cancer Center Orlando, Orlando Regional HealthcareOrlando, Florida  32806
Lake County Oncology and HematologyThe Villages, Florida  32159
Sinai Hospital - Alvin & Lois Lapidus Cancer InstituteBaltimore, Maryland  21215
Univeristy of Nebraska Medical CenterOmaha, Nebraska  68198
University of Rochester Cancer Center, James P. Wilmot Cancer CenterRochester, New York  14642
UPMC, Hillman Cancer CenterPittsburgh, Pennsylvania  15232
University of Tennessee, Boston Baskin Cancer Group, PLCMemphis, Tennessee  38104