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Trial record 83 of 178 for:    LENALIDOMIDE AND Leukemia

Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738829
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : August 30, 2013
Celgene Corporation
Roche Pharma AG
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Tracking Information
First Submitted Date  ICMJE August 20, 2008
First Posted Date  ICMJE August 21, 2008
Last Update Posted Date August 30, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
Lenalidomide Maximum Tolerated Dose [ Time Frame: Dose escalation stage ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00738829 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
  • Safety profile of Lenalidomide/Fludarabine/Rituximab treatment [ Time Frame: Study Duration ]
  • Safety Profile of Lenalidomide/Rituximab [ Time Frame: Study duration ]
  • Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment [ Time Frame: Dose escalation stage ]
  • Response rate for Lenalidomide/Rituximab combination therapy [ Time Frame: Study Duration ]
  • Response rate by 4-colour flow cytometric MRD analysis [ Time Frame: Study Duration ]
  • Changes in Quality of Life scores [ Time Frame: Study Duration ]
  • Risk factors and clonal evolution [ Time Frame: Study Duration ]
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 Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
Official Title  ICMJE Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.
Brief Summary The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
Detailed Description This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Lymphocytic, Chronic, B-Cell
Intervention  ICMJE
  • Drug: Lenalidomide

    Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity.

    During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage.

    Other Name: Revlimid
  • Drug: Fludarabine
    25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
    Other Name: Fludarabine phosphate
  • Biological: Rituximab

    Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6.

    Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage.

    Other Name: MabThera
Study Arms  ICMJE Experimental: Treatment Arm
Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
  • Drug: Lenalidomide
  • Drug: Fludarabine
  • Biological: Rituximab
Publications * Egle A, Steurer M, Melchardt T, Weiss L, Gassner FJ, Zaborsky N, Geisberger R, Catakovic K, Hartmann TN, Pleyer L, Voskova D, Thaler J, Lang A, Girschikofsky M, Petzer A, Greil R. Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study. Ann Hematol. 2018 Oct;97(10):1825-1839. doi: 10.1007/s00277-018-3380-z. Epub 2018 Jun 4. Erratum in: Ann Hematol. 2018 Jun 23;:.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2008)
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • B-CLL (CD23+, CD5+, CD19+, CD20+)
  • Treatment indication according to NCI criteria
  • Age >= 18 yrs
  • No previous treatment of CLL by chemo-, radio- or immunotherapy
  • Life expectancy > 6 months
  • Written informed consent
  • Women of non-childbearing potential or women of childbearing potential and men using effective contraception

Exclusion Criteria:

  • Active bacterial, viral or fungal infection
  • Positivity for HIV, Hepatitis B or C
  • Reduce organ functions and bone marrow dysfunction not due to CLL
  • Creatinine clearance below 30 ml/min
  • Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment
  • Patients with a history of severe cardiac disease
  • Other known co-morbidity with the potential to dominate survival
  • Transformation to aggressive B-cell malignancy
  • Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs
  • Pregnant or breast-feeding women
  • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
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 Austria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00738829
Other Study ID Numbers  ICMJE CLL-5
EudraCT Nr. 2008-001430-27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Sponsor  ICMJE Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators  ICMJE
  • Celgene Corporation
  • Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Richard Greil, Prof. Dr. Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg
PRS Account Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date August 2013

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