Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
Information source: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide (Drug); Fludarabine (Drug); Rituximab (Biological)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Arbeitsgemeinschaft medikamentoese Tumortherapie Official(s) and/or principal investigator(s): Richard Greil, Prof. Dr., Principal Investigator, Affiliation: Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg
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.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Lenalidomide Maximum Tolerated Dose
Secondary outcome: Safety profile of Lenalidomide/Fludarabine/Rituximab treatmentSafety Profile of Lenalidomide/Rituximab Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment Response rate for Lenalidomide/Rituximab combination therapy Response rate by 4-colour flow cytometric MRD analysis Changes in Quality of Life scores Risk factors and clonal evolution
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie, Innsbruck, Tirol A-6020, Austria
Additional Information
Starting date: October 2008
Last updated: August 29, 2013
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