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

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ClinicalTrials.gov Identifier: NCT00474188
Recruitment Status : Terminated (Business decision)
First Posted : May 16, 2007
Results First Posted : August 13, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Celgene

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: CC-5013 (lenalidomide) Drug: dexamethasone Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Tumor Response Rate [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Tumor Control Rate [ Time Frame: One Year ]
  2. Duration of Response [ Time Frame: One year ]
  3. Time to Progression [ Time Frame: One year ]
  4. Progression-free Survival [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474188


  Show 24 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Andrew Spencer, MD The Alfred
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Robert Knight, M.D., Celgene/sponsor
ClinicalTrials.gov Identifier: NCT00474188     History of Changes
Other Study ID Numbers: CC-5013-NHL-005
First Posted: May 16, 2007    Key Record Dates
Results First Posted: August 13, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009

Keywords provided by Celgene:
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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Lenalidomide
Thalidomide
BB 1101
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors