Clinical trial · Interventional
Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.
Summary
Brief summary (as posted)
This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.
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, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| galiximab in combination with rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies
- timeFrame
- Study period is approx. 2 years
Secondary outcomes (2)
- measure
- Pharmacokinetics
- timeFrame
- Study period is approx. 2 years
- measure
- To further characterize the efficacy profile of galiximab in combination with rituximab
- timeFrame
- Study period is approx. 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP \>=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC). * Bidimensionally measurable disease with at least 1 lesion \>=2.0 cm in a single dimension. * Acceptable hematologic, hepatic, and renal function. Key Exclusion Criteria: * Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study. * Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1. * Transfusion-dependent subjects. * Presence of central nervous system (CNS) lymphoma. * Histologic transformation. * Presence of pleural or peritoneal effusion with positive cytology for lymphoma. * Another primary malignancy requiring active treatment. * Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. * New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
References
Publications (0)
Data not yet available