Overview

Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

Status:
Completed
Trial end date:
2017-01-05
Target enrollment:
0
Participant gender:
All
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 the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Bayer
Treatments:
Molgramostim
Rituximab
Sargramostim
Criteria
Inclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Age 15 years or above.

5. 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.

6. Performance status <3 (Zubrod Scale).

7. No active viral hepatitis

Exclusion Criteria:

1) None.