Clinical trial · Interventional
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
NCT01275209CI-TRIAL-00048707LIFTcompletedPhase 1ClinicalTrials.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)
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular 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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCD122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCD122
- interventionNames
- Drug: HCD122
Primary outcomes (1)
- measure
- Incidence rate of dose-limiting toxicities and adverse events
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization \[REAL/WHO\] classification * Documented CD40+ follicular lymphoma * Measurable lesion * Refractory to rituximab * Prior treatment with at least 1 chemotherapeutic regimen * 18 years or older * WHO Performance Status grade 0, 1, or 2 * Life expectancy \> 3 months * Obtained written informed consent Exclusion Criteria: * Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL) * History of another primary malignancy that is currently clinically significant or currently requires active intervention * Prior allogeneic stem cell transplantation * Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * Impaired cardiac function or clinically significant cardiac disease * History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis * History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment. * Known diagnosis of human immunodeficiency virus (HIV) infection * Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C * Ongoing corticosteroid use (\>10 mg/day prednisone or equivalent) * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.