Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521638
Recruitment Status : Terminated
First Posted : August 28, 2007
Last Update Posted : January 14, 2013
Emergent Product Development Seattle LLC
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:

This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell Non-Hodgkin's Lymphoma (NHL).

TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data observed to date support its safety in patients with autoimmune disorders.

Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects with relapsed NHL (see inclusion criteria for subtypes).

Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Biological: TRU-015 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose Escalation Study of TRU-015 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma
Study Start Date : September 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1 Biological: TRU-015
Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks

Primary Outcome Measures :
  1. Safety: physical examinations, laboratory tests, adverse events. Maximum Tolerated Dose: dose-limiting toxicities. Efficacy: disease response and progression status per International Response Criteria for NHL. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Objective response rate in subjects with relapsed follicular NHL. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Subjects with CD20-positive, B cell NHL who, after at least 2 prior therapies of probable clinical benefit, have relapsed or refractory disease. The following histologies may be included*: lymphoplasmacytic lymphoma (formerly known as lymphoplasmacytoid lymphoma), splenic marginal zone B cell lymphoma, extranodal marginal zone B cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large-cell B cell lymphoma, and mediastinal large B cell lymphoma. Small lymphocytic lymphoma will be included if it is a primary diagnosis and if the lymphoma cells are < 5.0 x 109/L (5000/mm3) in the peripheral blood. *Subjects enrolled in the preliminary efficacy cohorts must have relapsed, refractory, or persistent follicular lymphoma (persistent disease defined as computed tomography (CT) positive for 3 months after last treatment), and must not have received anti-CD20 targeted therapy within 3 months of receiving the first dose of test article. Subjects may be considered eligible after a single therapy of probable clinical benefit, if no further standard effective treatment is available in the opinion of the investigator. Prior CD20 immunophenotyping of tumors to document B cell NHL is acceptable. If such prior documentation is not available, then the immunophenotype of the current disease must be documented by fine-needle aspirate or biopsy, or by circulating CD20-positive NHL cells from peripheral blood before administration of test article.
  • At least 1 measurable lesion that is 1.5 cm in at least 1 dimension by CT or magnetic resonance imaging (MRI), in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.
  • Recovery to baseline or grade 1 [according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0] from all acute adverse effects of prior therapies (excluding alopecia).

Main Exclusion Criteria:

  • Candidate for potentially curative therapy that is available to the subject, in the clinical opinion of the investigator.
  • Diagnosis of chronic lymphocytic leukemia, Burkitt's lymphoma, primary effusion lymphoma, and/or precursor B cell lymphoblastic lymphoma.
  • Prior treatments: radioimmunotherapy; allogeneic hematopoietic stem cell transplant (within 6 months of first dose of study drug); chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents (within 4 weeks of first dose of study drug); major surgery not related to debulking surgical procedures (within 3 weeks of first dose of study drug).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521638

United States, California
Duarte, California, United States, 91010
San Diego, California, United States, 92121
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
Buffalo, New York, United States, 14263
United States, Ohio
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Emergent Product Development Seattle LLC
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00521638     History of Changes
Other Study ID Numbers: 3206K2-104
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases