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A Phase 2/3 Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Phase 2/Phase 3
18 Years
Open (Enrolling)
Diffuse Large B-cell Lymphoma

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Trial Information

A Phase 2/3 Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This research study is for patients who have been diagnosed with Diffuse Large B-cell
Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after
chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called
lymphocytes. Diffuse Large B-cell Lymphoma (DLBCL)is just one type of lymphoma. Within
Diffuse Large B-cell Lymphoma (DLBCL) there are two different subtypes called GCB and
non-GCB which can be determined by cell surface marker tests or by gene expression tests.
Scientists can look at cells and genes in the laboratory and see that the two kinds are
different, but they don't know yet what the difference means. To patients and to doctors
these two kinds seem the same. Right now doctors don't usually do tests to find out which
kind a patient has because the treatment is the same for both.

This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate
patients by subtype and then test whether patients taking lenalidomide or any one of four
other drugs have a better response. It is possible that lenalidomide will work better than
one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the
subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of
Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the
four other drugs.

Inclusion Criteria:

- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).

- Relapsed or refractory to combination chemotherapy for Diffuse Large B-Cell Lymphoma
(DLBCL) that contains rituximab and an anthracycline, and one additional combination
chemotherapy or stem cell transplant.

- Measurable Diffuse Large B-Cell Lymphoma (DLBCL)disease by Computed Tomograph(CT) /
Magnetic Resonance Imagining (MRI).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

- Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).

- History of malignancies, other than Diffuse Large B-Cell Lymphoma (DLBCL), unless the
patient has been disease free for 3 years or more.

- Eligible for autologous stem cell transplant.

- Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

- Neuropathy grade 4.

Type of Study:


Study Design:

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

Outcome Measure:

Stage 1: Overall response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients

Outcome Description:

Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Outcome Time Frame:

Approximately 3 years

Safety Issue:


Principal Investigator

Oliver Manzke, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

June 2016

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Non Hodgkin's Lymphoma
  • relapsed
  • refractory
  • relapsed/refractory
  • Diffuse Large B Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



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