Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
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Purpose
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias.
In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma B Chronic Lymphocytic Leukemia |
Drug: Lenalidomide Drug: Bendamustine Drug: Rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study |
- Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- Clinical efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]response rate, progression-free and overall survival
| Estimated Enrollment: | 34 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
-
Drug: Lenalidomide
- CC-5013
- Revlimid
- Treanda
- SDX 105
- Rituxan
- Mabthera
Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on day 1 of each cycle.
Subjects will receive routine blood tests and physical exam during each cycle. Tumor assessments by CT scan will be performed during cycles 2, 4, and 6.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
- Life expectancy > 3 months
- Organ and marrow function with protocol parameters
- Able to take aspirin daily
Exclusion Criteria:
- Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
- Pregnant or breast-feeding
- Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
- Known hypersensitivity to thalidomide or lenalidomide
- Prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments
- HIV positive
- Prior history of another malignancy unless disease free for at least 2 years
- Uncontrolled intercurrent illness
Contacts and Locations| Contact: Christine Connolly | 617-726-5131 | cconnolly1@partners.org |
| Contact: Jeremy S Abramson, M.D. | 617-726-8743 | jabramson@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Principal Investigator: Jeremy Abramson, M.D. | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Jennifer Brown, M.D. | |
| Principal Investigator: | Jeremy Abramson, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01400685 History of Changes |
| Other Study ID Numbers: | 11-016 |
| Study First Received: | April 11, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
CLL Leukemia Untreated B-CLL SLL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine Rituximab Lenalidomide Thalidomide |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013