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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00670592

Collaborator

XOMA (US) LLC (Industry)

111

Enrollment

Locations

Arm

59.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Hodgkin's Lymphoma	Drug: HCD122	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: HCD122	Drug: HCD122

Arm

Intervention/Treatment

Other: HCD122

Drug: HCD122

Outcome Measures

Primary Outcome Measures

Primary endpoints (phase I) - Incidence rate of DLT and AE [2 years]
Primary endpoint (phase II) - Response rate [2 years]

Secondary Outcome Measures

Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611
2	St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)	Beech Grove	Indiana	United States	46107
3	Dana Farber Cancer Institute SC-5	Boston	Massachusetts	United States	02115
4	Wake Forest University Baptist Medical Center Dept. of Industry Research (2)	Winston-Salem	North Carolina	United States	27157
5	University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)	Houston	Texas	United States	77030-4009
6	Novartis Investigative Site	Parkville	Victoria	Australia	3050
7	Novartis Investigative Site	Prahran	Victoria	Australia	3181
8	Novartis Investigative Site	Gent		Belgium	9000
9	Novartis Investigative Site	Godinne		Belgium	5530
10	Novartis Investigative Site	Leuven		Belgium	3000
11	Novartis Investigative Site	Toronto	Ontario	Canada	M5G 2M9
12	Novartis Investigative Site	Montreal	Quebec	Canada	H3T 1E2
13	Novartis Investigative Site	Creteil		France	94010
14	Novartis Investigative Site	Le Mans Cedex		France	72015
15	Novartis Investigative Site	Lille Cedex		France	59 037
16	Novartis Investigative Site	Montpellier cedex 5		France	34295
17	Novartis Investigative Site	Paris		France	75475
18	Novartis Investigative Site	Pierre-Benite Cédex		France	F-69495
19	Novartis Investigative Site	Berlin		Germany	12200
20	Novartis Investigative Site	Köln		Germany	50924
21	Novartis Investigative Site	Hong Kong		Hong Kong
22	Novartis Investigative Site	Bologna	BO	Italy	40138
23	Novartis Investigative Site	Milano	MI	Italy	20133
24	Novartis Investigative Site	Pisa	PI	Italy	56126
25	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	110 744
26	Novartis Investigative Site	Singapore		Singapore	169608
27	Novartis Investigative Site	Leicester		United Kingdom	LE1 5WW
28	Novartis Investigative Site	London		United Kingdom	EC1A 7BE