Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

NCT ID: NCT00670592

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-02-28

Brief Summary

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This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCD122

Group Type OTHER

HCD122

Intervention Type DRUG

Interventions

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HCD122

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be included in the study if they meet all of the following criteria:

* Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification
* Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)
* Patients must be ≥ 18 years
* Patients must have life expectancy \> 3 months
* Patient must have adequate laboratory results
* Patients must have WHO Performance Status grade 0, 1, or 2
* Patients must have at least one site of measurable disease
* Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
* Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:

* Patients who have been treated with any anti-CD40 antibody
* Patients who have received prior allogeneic stem cell transplant
* Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
* Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
* Women of child-bearing potential (WCBP) who are pregnant or breast feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XOMA (US) LLC

INDUSTRY

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticlas

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

Beech Grove, Indiana, United States

Site Status

Dana Farber Cancer Institute SC-5

Boston, Massachusetts, United States

Site Status

Wake Forest University Baptist Medical Center Dept. of Industry Research (2)

Winston-Salem, North Carolina, United States

Site Status

University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

Houston, Texas, United States

Site Status

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status

Novartis Investigative Site

Prahran, Victoria, Australia

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Godinne, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Créteil, , France

Site Status

Novartis Investigative Site

Le Mans, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Pierre-Benite Cédex, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Bologna, BO, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Hong Kong Italy Singapore South Korea United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10903

Results for CHCD122A2103 from the Novartis Clinical Trials website

Other Identifiers

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2007-004888-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CHCD122A2103

Identifier Type: -

Identifier Source: org_study_id

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