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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


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 treatment

Safety 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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