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Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Nashville, Tennessee, 37203 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Large B-Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma, Transformed Indolent 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.
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- Age 18 years or older and willing and able to provide informed consent;

- Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent
lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;

- Received prior treatment with a standard anthracycline and therapeutic anti-CD20
monoclonal antibody-based regimen;

- For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment
must have resulted in a PR or stable disease;

- For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT
just prior to MDV9300 treatment must have resulted in a PR or stable disease;

- Adequate bone marrow reserve as defined per protocol;

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable
ECOG scores of 2 may be allowed with medical monitor approval.

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

- Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma

- History of serious autoimmune disease;

- History of central nervous system involvement of lymphoma;

- Prior therapy with agents targeting immune coinhibitory receptors.

NCT02653989
Pfizer
Withdrawn
Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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Pfizer Clinical Trials Contact Center

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[email protected]

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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