Phase 2
N=130
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00940342 ↗Enrolled (actual)
130
Serious AEs
9.2%
Results posted
Sep 2018
Primary outcome: Primary: Overall Response Rate — 23; 31; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GM-CSF (Sargramostim) (Drug); Rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
23; 31; 23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT00940342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.