Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

Phase 1

Completed

• Conditions: Follicular Lymphoma
• Interventions: Drug: HCD122

• Registration Number: NCT01275209
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Study Start: 2011-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCD122	HCD122	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of dose-limiting toxicities and adverse events	2 years

Secondary Outcome Measures

Name	Time	Method
Response rate	2 years

Trial Locations

Locations (5)

Sarah Cannon Research Institute SC - 2; 🇺🇸 Chattanooga, Tennessee, United States

Dana Farber Cancer Institute SC-5; 🇺🇸 Boston, Massachusetts, United States

Novartis Investigative Site; 🇪🇸 Madrid, Spain

Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6); 🇺🇸 Detroit, Michigan, United States

Duke University Medical Center Duke Hem & Onc; 🇺🇸 Durham, North Carolina, United States