A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diffuse Large B-cell Lymphoma | Drug: CC-5013 (lenalidomide) Drug: dexamethasone | Phase 2 |
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 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 |
| 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:
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 |
- Tumor Response Rate [ Time Frame: One Year ]
- Tumor Control Rate [ Time Frame: One Year ]
- Duration of Response [ Time Frame: One year ]
- Time to Progression [ Time Frame: One year ]
- Progression-free Survival [ Time Frame: One year ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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
| Principal Investigator: | Andrew Spencer, MD | The Alfred |
| 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 |