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

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate Lenalidomide

Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma

U.S. FDA Resources

Further study details as provided by Celgene:

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

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 (Adult, Senior)
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

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
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:


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 Dexamethasone 21-phosphate 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

ClinicalTrials.gov processed this record on September 26, 2016