Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Escalating Starting Dose of Lenalidomide and Concomitant Evaluation of Safety and Efficacy
This is a trial in patients with previously untreated CLL. Eligible patients will receive
Lenalidomide with a backbone of Fludarabine and Rituximab for 6 therapy cycles. Lenalidomide
will be increased by dose steps of 5 mg every cycle in the absence of limiting toxicity. If
limiting toxicity ensues the patients will be treated with last tolerable dose for the
remainder of the 6 treatment cycles.
The first 5 patients will start with dose level 5 mg Lenalidomide and further escalating
dose. After the fifth patient is included in the study, enrolment will be interrupted until
this patient has finished his first treatment cycle. A safety board will evaluate the
toxicities of the first 5 patients. If there are more than 2 patients experiencing a dose
limiting toxicity (DLT) in the first treatment cycle, the starting dose will not be
escalated and further 5 patients will be enrolled with a starting dose of 5 mg Lenalidomide.
If only 2 or less patients experience a DLT in the first treatment cycle, the next 5
patients will start the treatment with 10 mg Lenalidomide.
The rational for the higher starting doses stems from the lack of tumor lysis or tumor flare
toxicity in this combination on the one hand and from the observation that the very slow
escalation from 2,5 mg on led to a lack of efficacy in monotherapy trials due to early
progression in a relevant number of cases. The increase of the Lenalidomide dosage should
result in an increased efficacy especially at the beginning and a higher cumulative dose of
Lenalidomide.
The identification of patients intolerant to Lenalidomide by immunophenotyping of the T
cells for validation is also part of this trial, because intolerance seems to be not dose
dependent but may be caused by T cell activation. Therefore, early identification of
patients intolerant to this form of modern immunochemotherapy and establishing efficient
Lenalidomide based combination therapy is an important part of improvement of current CLL
treatment.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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