Clinical trial · Interventional
Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia
A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
- 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works in treating patients with B-cell chronic lymphocytic leukemia.
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 |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria:
* Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following:
* Weight loss \> 10% within the past 6 months
* Extreme fatigue
* Fever or night sweats without evidence of infection
* Worsening anemia or thrombocytopenia
* Progressive lymphocytosis with a rapid lymphocyte doubling time
* Marked hypogammaglobulinemia or paraproteinemia
* Lymphadenopathy \> 5 cm in diameter
* Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin \> 3.0 mg/mL
* Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible
PATIENT CHARACTERISTICS:
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin \< 2.0 mg/dL\* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: \*Liver dysfunction due to lymphocytic organ infiltration allowed
Renal
* Creatinine \< 2.5 mg/dL\* NOTE: \*Renal dysfunction due to lymphocytic organ infiltration allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active viral infection (e.g., viral hepatitis)
PRIOR CONCURRENT THERAPY:
Chemotherapy
* See Disease CharacteristicsReferences
Publications (0)
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