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A Phase 2, Multicenter, Randomized Open-Label Study to Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma


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

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Trial Information

A Phase 2, Multicenter, Randomized Open-Label Study to Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma


Inclusion Criteria:



- Biopsy proven mantle cell lymphoma

- Patients who are refractory to their regimen or have relapsed once, twice or up to
three times and who have documented progressive disease

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

- Willing to follow pregnancy precaution

Exclusion Criteria:

- Any of the following laboratory abnormalities

- Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1.5 x 10^9/L)

- Platelet count < 60,000/mm^3 (60 x 10^9/L)

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

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

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

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

- Subjects not willing to take Deep venous thrombosis (DVT) prophylaxis

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
sero-positive because of hepatitis B virus vaccine are eligible

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

Ongoing

Safety Issue:

No

Principal Investigator

Marek Trneny, MD/PhD/Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CC-5013-MCL-002

NCT ID:

NCT00875667

Start Date:

April 2009

Completion Date:

July 2017

Related Keywords:

  • Mantle Cell Lymphoma
  • Lymphoma, Mantle-cell
  • Mantle Cell Lymphoma
  • Relapsed Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Lymphoma
  • MCL
  • Lymphoma
  • Lymphoma, Mantle-Cell

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