Clinical trial · Interventional
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Rituximab In Combination With Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia (CLL)
NCT00940342CI-TRIAL-00034963completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF (Sargramostim) | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treated and Relapsed - Group 1
- description
- Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
- interventionNames
- Drug: GM-CSF (Sargramostim)
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Treated and High-Risk for Progression - Group 2
- description
- Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
- interventionNames
- Drug: GM-CSF (Sargramostim)
- Drug: Rituximab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.