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:
Collaborators:
Celgene Corporation
Cephalon
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00864942
First received: March 17, 2009
Last updated: June 18, 2014
Last verified: June 2014
  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 2015
Estimated Primary Completion Date: February 2015 (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:
  • Bendamustine HCL
  • Treanda
  • Revlimid
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:
  • Bendamustine HCL
  • Treanda
  • Revlimid
  • Rituxan
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:
  • Bendamustine HCL
  • Treanda
  • Revlimid
  • Rituxan
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:
  • Bendamustine HCL
  • Treanda
  • Revlimid

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
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, see Learn About Clinical Studies.

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: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
CLL
NHL
lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Lenalidomide
Bendamustine
Thalidomide
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 18, 2014