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

December 6, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Prahran, Victoria, Australia, 3181
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • France
      • Paris, France, 75475
        • Novartis Investigative Site
  • Italy
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Novartis Investigative Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute SC-5
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Duke Hem & Onc
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Sarah Cannon Research Institute SC - 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCD122
Drug: HCD122
Other Names:
  • Lucatumumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of dose-limiting toxicities and adverse events
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHCD122A2104
  • 2010-022350-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Follicular Lymphoma

Clinical Trials on HCD122

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe