Phase I/II Study of the Activity and Safety of Lenalidomide and Rituximab as Non-chemotherapy Therapy for Patients With Recurrent and Refractory Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
Phase I/II Study of the Activity and Safety of Lenalidomide and Rituximab as Non-chemotherapy Therapy for Patients With Recurrent and Refractory Chronic Lymphocytic Leukemia
Inclusion Criteria:
- Recurrent and refractory CLL patients that have received at least one previous
treatment with purine analogs.
- Adequate liver function and renal function.
- ECOG performance status ≤ 2.
- Signed informed consent
- Male and female patients who are fertile agree to use an effective barrier method of
birth control to avoid pregnancy.
Exclusion Criteria:
- Positive serological markers for hepatitis B with the exception of HBsAc in
previously vaccined patients
- Pregnant patients
- HIV infection
- Concurrent chemotherapy or immunotherapy
- Other malignancy within the last 2 years, except for localized cutaneous carcinoma
- Neurological impairment precluding understanding of protocol and the entailed visits
and procedures.
- Patients with Renal insuficiency that requires dialysis.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase I: To determine Starting Recommended Dose for the first cycle and the subsequent cycles (Maximal Tolerated Dose)in relapsed B-cell CLL patients Phase II: To determine the clinical response rate (combined morphological and flow cytometry criteria).
Outcome Description:
6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression. Module I: patients on every cohort will have the same dose during treatment, except if they experiment DLT, in which case dose will be decreased (unless they are on the first dose level). Module II: confirmation of the DLT, patients will have incresing dose on every cycle in order to confirm the DLT
Outcome Time Frame:
5 months
Safety Issue:
Yes
Authority:
Spain: Spanish Agency of Medicines
Study ID:
LLC-LENAR-08
NCT ID:
NCT01185262
Start Date:
April 2009
Completion Date:
November 2012
Related Keywords:
- Chronic Lymphocytic Leukemia
- Recurrent and refractory chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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