Clinical trial · Interventional
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
NCT00308087CI-TRIAL-00013243PREMIERterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated by sponsor due to low enrollment; see details below
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
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, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| Sargramostim (Leukine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Rituximab
- interventionNames
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Rituximab + Sargramostim
- interventionNames
- Drug: Sargramostim (Leukine)
- Drug: Rituximab
Primary outcomes (1)
- measure
- Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
- timeFrame
- Week 8 (confirmed at Week 12)
- description
- Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (abbreviated list): * Relapsed follicular B-cell lymphoma * One or more previous therapies for non-Hodgkin's * At least one measurable tumor by CT scan or MRI * Additional criteria to be determined at screening visit Exclusion Criteria (abbreviated list): * Rituximab refractory (less than 6 months from last treatment with rituximab to relapse) * Currently receiving treatment for another cancer * Infection currently being treated * Active Hepatitis B * History of HIV infection * Pregnant * Additional criteria to be determined at screening visit
References
Publications (0)
Data not yet available
No reference posted for this study.