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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apolizumab
Sponsored by
PDL BioPharma, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Protein Design Labs, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
December 17, 2013
Sponsor
PDL BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00014664
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2002
Overall Recruitment Status
Unknown status
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
PDL BioPharma, Inc.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
apolizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tillman Pearce, MD
Organizational Affiliation
Facet Biotech
Official's Role
Study Chair
Facility Information:
Facility Name
Protein Design Labs, Inc.
City
Freemont
State/Province
California
ZIP/Postal Code
94555
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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