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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00670592




Registration number
NCT00670592
Ethics application status
Date submitted
30/04/2008
Date registered
2/05/2008
Date last updated
23/01/2014

Titles & IDs
Public title
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
Scientific 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)
Secondary ID [1] 0 0
2007-004888-22
Secondary ID [2] 0 0
CHCD122A2103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HCD122

Other: HCD122 -


Treatment: Drugs: HCD122


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary endpoints (phase I) - Incidence rate of DLT and AE
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Primary endpoint (phase II) - Response rate
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [2] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Godinne
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
France
State/province [11] 0 0
Creteil
Country [12] 0 0
France
State/province [12] 0 0
Le Mans Cedex
Country [13] 0 0
France
State/province [13] 0 0
Lille Cedex
Country [14] 0 0
France
State/province [14] 0 0
Montpellier cedex 5
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Pierre-Benite Cédex
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Köln
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Italy
State/province [20] 0 0
BO
Country [21] 0 0
Italy
State/province [21] 0 0
MI
Country [22] 0 0
Italy
State/province [22] 0 0
PI
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Korea
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leicester
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
XOMA (US) LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00670592
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications