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

Last updated on March 15, 2019

Study Location
Duarte, California, 91010 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
B-Cell Lymphoma
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 (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).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).

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


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