Clinical trial · Interventional
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients
Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)
NCT00323557CI-TRIAL-00008602completedPhase 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 see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
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 |
|---|---|---|---|
| Pneumococcal Vaccine | Biological | — | UNRESOLVED |
| Sargramostim (GM-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pneumococcal Vaccine + GM-CSF
- description
- Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
- interventionNames
- Drug: Sargramostim (GM-CSF)
- type
- EXPERIMENTAL
- label
- Pneumococcal Vaccine Alone
- description
- First vaccine dose subcutaneously, Day 0.
- interventionNames
- Biological: Pneumococcal Vaccine
Primary outcomes (1)
- measure
- Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1\) Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4. Exclusion Criteria: 1. Patients will not be entered while neutropenic (PMNs \< 500 cells/mm3) or having received Rituximab within 6 months. 2. Patients will not be entered while febrile (Temperature \> 38 degrees C) within 1 week. 3. Active infection. 4. Patients with known Human immunodeficiency virus (HIV) infection. 5. Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine. 6. Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks. 7. Patients who have previously received pneumococcal vaccine within the preceding 12 months. 8. Absolute lymphocyte count less than 500 cells/mm3.
References
Publications (1)
- DERIVEDSafdar A, Rodriguez GH, Rueda AM, Wierda WG, Ferrajoli A, Musher DM, O'Brien S, Koller CA, Bodey GP, Keating MJ. Multiple-dose granulocyte-macrophage-colony-stimulating factor plus 23-valent polysaccharide pneumococcal vaccine in patients with chronic lymphocytic leukemia: a prospective, randomized trial of safety and immunogenicity. Cancer. 2008 Jul 15;113(2):383-7. doi: 10.1002/cncr.23561. PMID 18470901