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

Purpose

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.

Condition	Intervention	Phase
Lymphocytic Leukemia, Chronic	Drug: RO5072759	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Objective response rate (complete response/complete response with incomplete marrow recovery/partial response), assessments according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival, defined as the time from the randomization to the first occurrence of progression or death, whichever occurs first [ Time Frame: up to 3.5 years ] [ Designated as safety issue: No ]
Duration of response, defined as the first occurrence of a documented, objective response until the first occurrence of relapse or progression or death from any cause [ Time Frame: up to 3.5 years ] [ Designated as safety issue: No ]
Overall survival, defined as the time from randomization until death from any cause [ Time Frame: up to 3.5 years ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Nature of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Severity of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Pharmacokinetic parameters derived from plasma concentration-time profiles of GA101 following administration [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Pharmacodynamics: Peripheral blood B-cell depletion and recovery [ Time Frame: Up to Day 141 ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	October 2011
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: RO5072759 Repeating 1000 mg intravenous dose Other Name: GA101
Active Comparator: B	Drug: RO5072759 Repeating 2000 mg intravenous dose \n\n\n Other Name: GA101

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414205

Show 29 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Jamie Hirata, Pharm.D

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01414205 History of Changes
Other Study ID Numbers:	GAO4768g, GO25677
Study First Received:	August 10, 2011
Last Updated:	November 12, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013