Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
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.
3 other identifiers
interventional
45
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedAugust 30, 2013
August 1, 2013
3.3 years
August 20, 2008
August 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lenalidomide Maximum Tolerated Dose
Dose escalation stage
Secondary Outcomes (7)
Safety profile of Lenalidomide/Fludarabine/Rituximab treatment
Study Duration
Safety Profile of Lenalidomide/Rituximab
Study duration
Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment
Dose escalation stage
Response rate for Lenalidomide/Rituximab combination therapy
Study Duration
Response rate by 4-colour flow cytometric MRD analysis
Study Duration
- +2 more secondary outcomes
Study Arms (1)
Treatment Arm
EXPERIMENTALLenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
Interventions
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.
25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arbeitsgemeinschaft medikamentoese Tumortherapielead
- Celgene Corporationcollaborator
- Roche Pharma AGcollaborator
Study Sites (7)
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, A-6020, Austria
Landeskrankenhaus Feldkirch
Feldkirch, A-6806, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, A-4010, Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz, A-4010, Austria
Krankenhaus der Stadt Linz
Linz, A-4020, Austria
Universitaetsklinik f. Innere Medizin III
Salzburg, A-5020, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, A-4600, Austria
Related Publications (1)
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.
PMID: 29862437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Greil, Prof. Dr.
Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 21, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
August 30, 2013
Record last verified: 2013-08