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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma

Thank you

Trial Information

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)

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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CHCD122A2103

NCT ID:

NCT00670592

Start Date:

March 2008

Completion Date:

September 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • HCD122
  • CD40
  • NHL
  • HL
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Northwestern UniversityChicago, Illinois  60611
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)Beech Grove, Indiana  46107
Dana Farber Cancer Institute SC-5Boston, Massachusetts  02115
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)Winston-Salem, North Carolina  27157
MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(3)Houston, Texas  77030-4009