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Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Collaborating Sponsors:

XOMA (US) LLC

Conditions:

Non-Hodgkin's Lymphoma

Hodgkin's Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2013

    Estimated Enrollment :

    111 Patients enrolled

    Trial Details

    Trial ID

    NCT00670592

    Start Date

    March 1 2008

    End Date

    February 1 2013

    Last Update

    December 17 2020

    Active Locations (28)

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    Page 1 of 7 (28 locations)

    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