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

Primary Purpose

Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HCD122
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring HCD122, CD40, NHL, HL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Northwestern University
  • St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
  • Dana Farber Cancer Institute SC-5
  • Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
  • University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HCD122

Arm Description

Outcomes

Primary Outcome Measures

Primary endpoints (phase I) - Incidence rate of DLT and AE
Primary endpoint (phase II) - Response rate

Secondary Outcome Measures

Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression

Full Information

First Posted
April 30, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
Collaborators
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00670592
Brief Title
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
Official Title
A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
XOMA (US) LLC

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
Keywords
HCD122, CD40, NHL, HL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCD122
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
HCD122
Primary Outcome Measure Information:
Title
Primary endpoints (phase I) - Incidence rate of DLT and AE
Time Frame
2 years
Title
Primary endpoint (phase II) - Response rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticlas
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Dana Farber Cancer Institute SC-5
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans Cedex
ZIP/Postal Code
72015
Country
France
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59 037
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Novartis Investigative Site
City
Pierre-Benite Cédex
ZIP/Postal Code
F-69495
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Novartis Investigative Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10903
Description
Results for CHCD122A2103 from the Novartis Clinical Trials website

Learn more about this trial

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

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