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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01275209
First received: January 10, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Follicular Lymphoma
 Drug: HCD122
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence rate of dose-limiting toxicities and adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCD122 Drug: HCD122
Other Name: Lucatumumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275209

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01275209     History of Changes
Other Study ID Numbers: CHCD122A2104, 2010-022350-17
Study First Received: January 10, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Italy: Italian Pharmaceutical Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Netherlands: Medicines Evaluation Board
Spain: Medicines and Health Products Agency (AEMPS)
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
HCD122
Lucatumumab
CD40
 Follicular Lymphoma
Non-Hodgkin's Lymphoma
Antibody

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
 Bendamustine
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013