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A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study has been terminated.
(Business decision)
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00474188
First received: May 14, 2007
Last updated: August 27, 2009
Last verified: August 2009

May 14, 2007
August 27, 2009
May 2007
December 2008   (final data collection date for primary outcome measure)
Tumor Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00474188 on ClinicalTrials.gov Archive Site
  • Tumor Control Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
  • Drug: CC-5013 (lenalidomide)
    Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
    Other Names:
    • CC-5013
    • lenalidomide
    • Revlimid
  • Drug: dexamethasone
    Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
    Other Name: Decadron
Experimental: Single Arm
Interventions:
  • Drug: CC-5013 (lenalidomide)
  • Drug: dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00474188
CC-5013-NHL-005
Yes
Robert Knight, M.D., Celgene/sponsor
Celgene Corporation
Not Provided
Principal Investigator: Andrew Spencer, MD The Alfred Hospital
Celgene Corporation
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP