Status:
COMPLETED
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer
Conditions:
Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow ...
Detailed Description
GM-CSF is a drug designed to stimulate the immune system. It will increase the number of a certain type of blood cell called neutrophils and macrophages. Rituximab is a drug designed to bind to a pro...
Eligibility Criteria
Inclusion
- Group 1. Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the NCI-sponsored working group 1) weight loss of \>10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy \>5 cm in diameter.
- Group 2. Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high risk for progression based on B2-microglobulin \>3.0 mg/mL, or with symptoms or significant fatigue.
- Group 3. Patients age 70 years of age and older with previously untreated B-CLL and Rai stage III-IV or earlier stage disease with indication for treatment who refused chemotherapy.
- Age 15 years or above.
- Adequate renal and hepatic functions (creatinine \<2.5 mg/dL, bilirubin \<2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are eligible, as are patients with elevated bilirubin and history consistent with Gilbert's disease.
- Performance status \<3 (Zubrod Scale).
- No active viral hepatitis
Exclusion
- 1\) None.
Key Trial Info
Start Date :
October 12 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00940342
Start Date
October 12 2004
End Date
January 5 2017
Last Update
September 19 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030