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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01275209

Acronym

LIFT

Enrollment

Registered

2011-01-12

Start date

2011-02-28

Completion date

2012-05-31

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Keywords

HCD122, Lucatumumab, CD40, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Antibody

Brief summary

This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

Interventions

DRUGHCD122

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Incidence rate of dose-limiting toxicities and adverse events	2 years

Secondary

Measure	Time frame
Response rate	2 years

Countries

Australia, Belgium, Canada, France, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026