Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase

Completed

Phase 2

Phase 1

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Treatments

Biological: Rituximab

Drug: Fludarabine

Drug: Lenalidomide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00738829

ML21718

EudraCT Nr. 2008-001430-27

CLL-5

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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