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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01275209
Collaborator
(none)
1
Enrollment
12
Locations
1
Arm
14.9
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: HCD122

Drug: HCD122
Other Names:
  • Lucatumumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of dose-limiting toxicities and adverse events [2 years]

    Secondary Outcome Measures

    1. Response rate [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01275209
    Other Study ID Numbers:
    • CHCD122A2104
    • 2010-022350-17
    First Posted:
    Jan 12, 2011
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2012
    Keywords provided by Novartis Pharmaceuticals
    HCD122
    Lucatumumab
    CD40
    Follicular Lymphoma
    Non-Hodgkin's Lymphoma
    Antibody
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular

    Study Results

    No Results Posted as of Dec 8, 2020