NCT01275209

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

January 10, 2011

Last Update Submit

December 6, 2020

Conditions

Follicular Lymphoma

Keywords

HCD122LucatumumabCD40Follicular LymphomaNon-Hodgkin's LymphomaAntibody

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of dose-limiting toxicities and adverse events

    2 years

Secondary Outcomes (1)

  • Response rate

    2 years

Study Arms (1)

HCD122

EXPERIMENTAL
Drug: HCD122

Interventions

HCD122DRUG
Also known as: Lucatumumab
HCD122

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • WHO Performance Status grade 0, 1, or 2
  • Life expectancy \> 3 months
  • Obtained written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dana Farber Cancer Institute SC-5

Boston, Massachusetts, 02115, United States

Location

Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)

Detroit, Michigan, 48201, United States

Location

Duke University Medical Center Duke Hem & Onc

Durham, North Carolina, 27710, United States

Location

Sarah Cannon Research Institute SC - 2

Chattanooga, Tennessee, 37404, United States

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Torino, TO, 10126, Italy

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Related Links

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Non-Hodgkin

Interventions

lucatumumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 8, 2020

Record last verified: 2012-12

Locations

BE(2)CA(1)IT(1)FR(1)ES(2)AU(1)US(4)