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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (complete response/complete response with incomplete marrow recovery/partial response), assessments according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines

Outcome Time Frame:

Week 24

Safety Issue:

No

Principal Investigator

Jamie Hirata, Pharm.D

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GAO4768g

NCT ID:

NCT01414205

Start Date:

October 2011

Completion Date:

July 2016

Related Keywords:

  • Lymphocytic Leukemia, Chronic
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Chronic Disease

Name

Location

Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
McLean, Virginia  22101
Hackensack, New Jersey  07601
Denver, Colorado  
Eugene, Oregon  
Indianapolis, Indiana  
Tulsa, Oklahoma  
Coeur D'alene, Idaho  83814