- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864942
Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) (Phase I BLR)
March 12, 2015 updated by: Georgetown University
Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University Hospital/Lombardi Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BL-NHL
Bendamustine and lenalidomide for 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
|
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
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: 2 years
|
2 years
|
Dose limiting toxicity
Time Frame: 2 years
|
2 years
|
Recommended Phase II dose
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall safety profile
Time Frame: 2 years
|
2 years
|
Plasma pharmacokinetics
Time Frame: 2 years
|
2 years
|
Preliminary antitumor activity
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 18, 2009
First Posted (ESTIMATE)
March 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 13, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Bendamustine Hydrochloride
- Rituximab
Other Study ID Numbers
- RV-CLL-NHL-PI-356
- 2008-186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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