Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) (Phase I BLR)
This study is ongoing, but not recruiting participants.
Sponsor:
Georgetown University
Collaborators:
Celgene Corporation
Cephalon
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00864942
First received: March 17, 2009
Last updated: February 8, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is for subjects with a B-cell lymphoid malignancy (lymphoma) or chronic lymphocytic leukemia (CLL) that has come back after or did not get better with previous treatment. The purpose of this study is to find out the highest dose of lenalidomide that can be given together with bendamustine and rituximab. The study will also look what effects the combination of lenalidomide and bendamustine and the combination of lenalidomide, bendamustine and rituximab will have on patients and their disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia Non-Hodgkin's Lymphoma |
Drug: bendamustine and lenalidomide Drug: BL-NHL Drug: BLR-CLL Drug: BLR-NHL |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies |
Resource links provided by NLM:
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- Maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Dose limiting toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Recommended Phase II dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- overall safety profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Plasma pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Preliminary antitumor activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BL-NHL
Bendamustine and lenalidomide for NHL
|
Drug: BL-NHL
Bendamustine HCL 90 mg/m2 given intravenously over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.
Other Names:
|
|
Experimental: BLR-CLL
Bendamustine, lenalidomide, rituximab for CLL
|
Drug: BLR-CLL
Lenalidomide is given orally for 7 days followed by rituximab 375 mg/m2 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.
Other Names:
|
|
Experimental: BLR-NHL
Bendamustine, lenalidomide, and rituximab for NHL
|
Drug: BLR-NHL
Rituximab 375 mg/m2 is given on day 1 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.
Other Names:
|
|
Experimental: BL-CLL
bendamustine and lenalidomide in patients with CLL
|
Drug: bendamustine and lenalidomide
Lenalidomide is given daily orally for one week followed by bendamustine HCL 90 mg/m2 IV over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.
Other Names:
|
Detailed Description:
This is a Phase I, open-label, dose-escalation study of bendamustine and lenalidomide (BL) and also bendamustine,lenalidomide, and rituximab (BLR) in relapsed/refractory CLL and relapsed/refractory B-cell lymphomas. Phase I dose escalation will be done independently for the CLL and NHL groups. In addition, the study will be conducted in 2 parts. In part I of the study, the maximum tolerated dose of bendamustine and lenalidomide will be determined independently for the CLL and NHL groups. In part II of the study, CLL and NHL subjects will be enrolled at the MTD of BL determined in Part I for CLL and NHL and all subjects will receive rituximab. Part II of the study will determine the MTD of BLT independently for the NHL and CLL groups.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented relapsed or refractory B-cell NHL; CD-20 positive tumor. Indolent NHL: follicular B-cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, transformed aggressive lymphomas, mantle cell lymphoma and chronic lymphocytic leukemia
- Maximum of 6 prior chemotherapy regimens. Prior rituximab is allowed.
- Bidimensionally measurable disease
- ECOG performance status 0-2
- Absolute neutrophil count >/= 1000 and platelet count >/= 50,000
- Serum creatinine </= 1.5 mg/dL
- Adequate hepatic function
- Estimated life expectancy of at least 3 months
- All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
- Able to take aspirin 81 mg daily as prophylactic anticoagulation
Exclusion Criteria:
- Chemotherapy or immunotherapy within 3 weeks prior to entering study or failure to recover from adverse events due to any agents administered previously
- Use of investigational agents within 28 days of study
- Hematopoietic growth factors within 14 days of study
- History of prior high dose chemotherapy with allogeneic stem cell support
- History of prior radioimmunotherapy </= 1 year
- Concurrent treatment with therapeutic doses of systemic steroids
- Pregnant or lactating female subjects
- Concurrent, active malignancy other than lymphoma or CLL
- Primary CNS lymphoma
- Patients with a prior diagnosis of lymphoma active in the CNS are eligible only if CNS has been treated, and they are neurologically stable with no progressive symptoms off steroids and anti-convulsants
- Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of study objectives
- Hypersensitivity to murine proteins or to any component of rituximab
- Known positive for HIV or infectious hepatitis type C; hepatitis type B that is active and uncontrolled
- Hypersensitivity to mannitol
- Evidence of laboratory tumor lysis syndrome by Cairo-Bishop criteria
- Subject with recent thromboembolic event (deep vein thrombosis or pulmonary embolism) unless clinically stable and event occurred more than 2 weeks prior to enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864942
Locations
| United States, District of Columbia | |
| Georgetown University Hospital/Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
Sponsors and Collaborators
Georgetown University
Celgene Corporation
Cephalon
Investigators
| Principal Investigator: | Bruce D Cheson, MD | Georgetown University |
More Information
No publications provided
| Responsible Party: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00864942 History of Changes |
| Other Study ID Numbers: | RV-CLL-NHL-PI-356, 2008-186 |
| Study First Received: | March 17, 2009 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgetown University:
|
CLL NHL lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine Rituximab Lenalidomide |
Nitrogen Mustard Compounds Thalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013