A Study Comparing RO5072759 (GA101) 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GAGE)

Status:	Recruiting
Conditions:	Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	11/11/2012
Start Date:	October 2011
End Date:	July 2016
Contact:	Please reference Study ID Number: GO25677 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia

This open-label, multicenter, randomized study will compare the efficacy, safety and
pharmacokinetics of RO5072759 (GA101) 1000 mg versus 2000 mg in patients with previously
untreated chronic lymphocytic leukemia. The randomization scheme will ensure approximately
equal sample sizes in the two treatment dose arms for the following stratification factors:
1) tumor burden at baseline (high or low); and 2) Rai stage at baseline (study entry; I/II
or III/IV). Tumor burden will be assessed on the basis of the presence or absence of at
least one nodal mass >/= 5 cm in the baseline computed tomography (CT) scan. Patients will
be randomized to receive a maximum of 8 cycles of GA101 (1000mg iv infusion, on days 1, 8
and 15 of cycle 1 and day 1 of cycles 2 - 6) on 21 day cycles or maximum of 8 cycles of
GA101 (2000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) on 21
day cycles.

Inclusion Criteria:

- CD20-positive B-cell chronic lymphocytic leukemia (per IWCLL guidelines)

- Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease
that requires treatment according to IWCLL guidelines

- No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no
previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or ITP; prior use
of steroids for AIHA or ITP is allowed

- Eastern Cooperative Oncology Group performance status of 0, 1 or 2

Exclusion Criteria:

- Transformation of CLL to aggressive B-cell malignancy

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

- Evidence of severe, uncontrolled concomitant disease

- Known active infection or any major episode of infection requiring treatment with IV
antibiotics or hospitalization within 4 weeks before the start of Cycle 1

- Seropositive for human immunodeficiency virus (HIV)

- Positive for chronic hepatitis B infection (defined as positive HBsAg serology)

- Positive for hepatitis C (hepatitis C virus [HCV] antibody serology testing)

- Pregnant or lactating women

- Concurrent (or within 7 days prior to fist dose of study treatment) systemic
corticosteroid use, except for low-dose corticosteroid therapy used to treat illness
other than lymphoma

We found this trial at

sites

Clinical Trial Facility in Birmingham Alabama

Birmingham, Alabama

from

Birmingham, AL