Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

December 17, 2013 updated by: PDL BioPharma, Inc.

A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.
  • Compare the preliminary tumor response and progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours on days 1, 8, 15, and 22.
  • Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.
  • Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.

Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Freemont, California, United States, 94555
        • Protein Design Labs, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma

  • Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL

    • Progression of disease or no response since last treatment for NHL
  • 1D10+ lymphoma by immunohistochemistry or flow cytometry
  • Bidimensionally measurable disease at least 2 cm in a single dimension
  • No CNS metastases
  • Circulating tumor cells no greater than 5,000/mm^3

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 75,000/mm^3 (unless disease related)
  • Neutrophil count at least 1,000/mm^3 (unless disease related)
  • Hemoglobin greater than 8.0 g/dL

Hepatic:

  • Bilirubin less than 2.5 mg/dL
  • SGOT less than 4 times upper limit of normal

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

  • No clinically significant cardiac disease (New York Heart Association class III or IV)
  • No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months

Pulmonary:

  • No clinically significant pulmonary disease

Other:

  • No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ
  • No significant psychiatric or CNS impairment
  • No active serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study
  • Negative anti-Hu1D10 antibody response (HAHA/HAMA)
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior interferon therapy
  • At least 3 months since prior immunotherapy
  • No prior monoclonal antibody Hu1D10

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day)
  • No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior external beam radiotherapy
  • At least 3 months since prior radioimmunotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent lymphoma therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PDL BioPharma, Inc.

Investigators

  • Study Chair: Tillman Pearce, MD, Facet Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

June 9, 2003

First Posted (Estimate)

June 10, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068585
  • PDL-1D10-901
  • CUMC-0101-552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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