Clinical trial · Interventional
GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment
- 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: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. 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. Giving GM-CSF together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| gene rearrangement analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall objective tumor response rate at the end of induction therapy
Secondary outcomes (8)
- measure
- Time to progression
- measure
- Overall survival
- measure
- Duration of response
- measure
- Time to next treatment
- measure
- Safety profile
- measure
- Influence of FcγR polymorphisms on clinical response and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification * Grade 1-3a disease * Stage II-IV disease * Non-bulky disease * Must have undergone initial nodal biopsy within the past 4 months * At least 1 measurable lesion * Low tumor-burden, as defined by the following GELF criteria: * Nodal or extranodal tumor mass (diameter \< 7 cm) * No systemic B symptoms * No increased LDH and β2 microglobulinemia * No substantial splenic enlargement * No serous effusion * No compression syndrome PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Negative pregnancy test * Fertile patients must use effective contraception * No active hepatitis PRIOR CONCURRENT THERAPY: * No prior treatment, including steroids and radiotherapy
References
Publications (0)
Data not yet available