You are here

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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
B-Cell Lymphoma
Sex
Females and Males
Age
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.
Show details

- 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.
Show details

- 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).

NCT00521638
Pfizer
Terminated
Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC), Diffuse Large B-Cell Lymphoma (DLBCL)
NCT03460977
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now