Status:
COMPLETED
Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Celgene Corporation
Roche Pharma AG
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ly...
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 lenalid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00738829
Start Date
October 1 2008
End Date
January 1 2012
Last Update
August 30 2013
Active Locations (7)
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1
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, Austria, A-6020
2
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
3
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria, A-4010
4
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria, A-4010