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.
18 Years
N/A
Both
Leukemia, Lymphocytic, Chronic, B-Cell
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Lenalidomide Maximum Tolerated Dose
Outcome Time Frame:
Dose escalation stage
Safety Issue:
Yes
Principal Investigator
Richard Greil, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg
Authority:
Austria: Agency for Health and Food Safety
Study ID:
CLL-5
NCT ID:
NCT00738829
Start Date:
October 2008
Completion Date:
December 2011
Related Keywords:
- Leukemia, Lymphocytic, Chronic, B-Cell
- CLL
- untreated
- immune therapy
- dose escalation
- maximum tolerated dose
- maintenance therapy
- Lenalidomide
- Rituximab
- Fludarabine
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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