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Trial record 98 of 178 for:    LENALIDOMIDE AND Leukemia

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

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ClinicalTrials.gov Identifier: NCT00864942
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 13, 2015
Sponsor:
Collaborators:
Celgene Corporation
Cephalon
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 19, 2009
Last Update Posted Date March 13, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2009)
  • Maximum tolerated dose [ Time Frame: 2 years ]
  • Dose limiting toxicity [ Time Frame: 2 years ]
  • Recommended Phase II dose [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00864942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2009)
  • overall safety profile [ Time Frame: 2 years ]
  • Plasma pharmacokinetics [ Time Frame: 2 years ]
  • Preliminary antitumor activity [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: BL-NHL
    Bendamustine and lenalidomide for NHL
    Intervention: Drug: BL-NHL
  • Experimental: BLR-CLL
    Bendamustine, lenalidomide, rituximab for CLL
    Intervention: Drug: BLR-CLL
  • Experimental: BLR-NHL
    Bendamustine, lenalidomide, and rituximab for NHL
    Intervention: Drug: BLR-NHL
  • Experimental: BL-CLL
    bendamustine and lenalidomide in patients with CLL
    Intervention: Drug: bendamustine and lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2015)
28
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2009)
96
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00864942
Other Study ID Numbers  ICMJE RV-CLL-NHL-PI-356
2008-186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE
  • Celgene Corporation
  • Cephalon
Investigators  ICMJE
Principal Investigator: Bruce D Cheson, MD Georgetown University
PRS Account Georgetown University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP