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Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) (Phase I BLR)

Primary Purpose

Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bendamustine and lenalidomide
BL-NHL
BLR-CLL
BLR-NHL
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, NHL, lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Georgetown University Hospital/Lombardi Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BL-NHL

BLR-CLL

BLR-NHL

BL-CLL

Arm Description

Bendamustine and lenalidomide for NHL

Bendamustine, lenalidomide, rituximab for CLL

Bendamustine, lenalidomide, and rituximab for NHL

bendamustine and lenalidomide in patients with CLL

Outcomes

Primary Outcome Measures

Maximum tolerated dose
Dose limiting toxicity
Recommended Phase II dose

Secondary Outcome Measures

overall safety profile
Plasma pharmacokinetics
Preliminary antitumor activity

Full Information

First Posted
March 17, 2009
Last Updated
March 12, 2015
Sponsor
Georgetown University
Collaborators
Celgene Corporation, Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00864942
Brief Title
Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
Acronym
Phase I BLR
Official Title
Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Celgene Corporation, Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
Keywords
CLL, NHL, lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BL-NHL
Arm Type
Experimental
Arm Description
Bendamustine and lenalidomide for NHL
Arm Title
BLR-CLL
Arm Type
Experimental
Arm Description
Bendamustine, lenalidomide, rituximab for CLL
Arm Title
BLR-NHL
Arm Type
Experimental
Arm Description
Bendamustine, lenalidomide, and rituximab for NHL
Arm Title
BL-CLL
Arm Type
Experimental
Arm Description
bendamustine and lenalidomide in patients with CLL
Intervention Type
Drug
Intervention Name(s)
bendamustine and lenalidomide
Other Intervention Name(s)
Bendamustine HCL, Treanda, Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BL-NHL
Other Intervention Name(s)
Bendamustine HCL, Treanda, Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BLR-CLL
Other Intervention Name(s)
Bendamustine HCL, Treanda, Revlimid, Rituxan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BLR-NHL
Other Intervention Name(s)
Bendamustine HCL, Treanda, Revlimid, Rituxan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
2 years
Title
Dose limiting toxicity
Time Frame
2 years
Title
Recommended Phase II dose
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall safety profile
Time Frame
2 years
Title
Plasma pharmacokinetics
Time Frame
2 years
Title
Preliminary antitumor activity
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce D Cheson, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital/Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)

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