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A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Diffuse Large B-cell Lymphoma

Thank you

Trial Information

A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent
lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis,
with median survival time as long as 10 years, but they are not usually curable in advanced
stages. Aggressive NHL constitutes about half of all cases of NHL in North America and
Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the
most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive
type of NHL has a shorter natural history; approximately 50-60% of these subjects can be
cured with combination chemotherapy regimens. Even with recent advances, many patients with
advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of
subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it
is important to test lenalidomide in DLBCL. Other studies are addressing the activity of
lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is
important to test lenalidomide in combination therapy. This study is focused on treating
subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral
dexamethasone.


Inclusion Criteria:



- Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma

- Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma

- Measurable disease on cross sectional imaging that is at least 2 cm in the longest
diameter

- ECOG performance score of 0,1 or 2

- Willing to follow the 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 SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).

- Serum total bilirubin > 2.0 mg/dL (34 µmol/L).

- Subjects who are candidates for and willing to undergo an autologous stem cell
transplant.

- History of active CNS lymphoma within the previous 3 months

- Subjects not willing or unable to take DVT prophylaxis

- History of other malignancies within the past year

- Positive HIV or active Hepatitis B or C

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate

Outcome Time Frame:

One Year

Safety Issue:

No

Principal Investigator

Andrew Spencer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Alfred Hospital

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-NHL-005

NCT ID:

NCT00474188

Start Date:

May 2007

Completion Date:

December 2008

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Celgene
  • Revlimid
  • Lenalidomide
  • Diffuse Large B-cell lymphoma
  • Non-Hodgkins lymphoma
  • CC-5013
  • Response Rate
  • Tumor Control Rate
  • Duration of Response
  • Time to Progression
  • Progression-free survival and safety
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Southwest Regional Cancer CenterAustin, Texas  78705
Tower Cancer Research FoundationBeverly Hills, California  90211
Northern Utah AssociatesOgden, Utah  84403
University of KentuckyLexington, Kentucky  40536-0098
Northwestern University, Feinberg School of MedicineChicago, Illinois  60611
Southwest Oncology AssociatesLafayette, Louisiana  70503
Hematology/Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
Northwest Georgia Oncology CentersMarietta, Georgia  30060
James Cancer HospitalColumbus, Ohio  43210
Kalamazoo Hematology & OncologyKalamazoo, Michigan  49048
Palo Verde Hematology/Oncology, Ltd.Glendale, Arizona  85204
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
New Bern Cancer CareNew Bern, North Carolina  28560
Advanced Medical SpecialtiesMiami, Florida  33176
Washington County Hospital, The Center for Clinical ResearchHagerstown, Maryland  21742
Oncology & Hematology Specialists, PADenville, New Jersey  07834
Northwestern Carolina, Oncology and Hematology PAHickory, North Carolina  28602