A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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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 |
- Tumor Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
- 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:
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00474188
Show 24 Study Locations
| 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 February 27, 2015