NCT00737529

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00737529

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

Summary

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Eligibility

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

Disease(s) and\or Condition(s)

Mantle Cell Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: lenalidomide
- Description: 25mg oral capsules continuous days 1-21 each of a 28 day cycle
- Arm Group Labels: Lenalidomide

Sponsor

Celgene