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CLL11: A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

2014-08-27 03:18:08 | BioPortfolio

Summary

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia. Patients will be randomized to receive a maximum of 6 cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2 cycle 1, 500mg/m2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphocytic Leukemia, Chronic

Intervention

RO5072759, rituximab, chlorambucil

Location

Buenos Aires
Alberta
Argentina
C1221ADC

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:08-0400

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Medical and Biotech [MESH] Definitions

A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.

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A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

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