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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
  Purpose

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: CC-5013 (lenalidomide)
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Tumor Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474188

  Show 24 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Andrew Spencer, MD The Alfred Hospital
  More Information

No publications provided

Responsible Party: Robert Knight, M.D., Celgene/sponsor
ClinicalTrials.gov Identifier: NCT00474188     History of Changes
Other Study ID Numbers: CC-5013-NHL-005
Study First Received: May 14, 2007
Results First Received: June 30, 2009
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Growth Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014