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

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma

Treatments

Drug: HCD122

Study type

Interventional

Funder types

Industry

Identifiers

NCT00670592

CHCD122A2103

2007-004888-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No 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