A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment with CHOP-based Chemotherapy
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with peripheral T-cll lymphoma (PTCL) who:
- Have completed at least 6 cycles of initial treatment with a CHOP-based therapy, and
- Had a partial or complete response to the therapy
CHOP-based therapy used to treat peripheral T-cell lymphoma (PTCL) may only work for a short period of time, and new treatments are needed to prolong response duration and survival.
The purpose of this study is to determine the effectiveness of the drug pralatrexate, compared to observation, in people with PTCL who have responded to CHOP therapy. Pralatrexate is an anti-metabolite drug that works in a similar way to methotrexate, a chemotherapy drug used for many types of cancer. Pralatrexate blocks how cells are made so the growth of the lymphoma can be slowed, stopped or decreased. It has been FDA-approved for treating relapsed or refractory PTCL.
Study participants will be randomly assigned to one of two study groups:
- Group 1, Observation Group: participants will see their physician and have blood drawn at least once a month
- Group 2, Pralatrexate Group: participants will receive pralatrexate via infusion once a week for 3 weeks of a 4-week cycle; participants may continue to receive pralatrexate for up to two years as long as they respond to and tolerate treatment
Participants have about a 66% chance of being assigned to the pralatrexate group and about a 33% chance of being in the observation group.
The study will determine if there is a difference in how long it takes for the lymphoma to progress or come back in participants receiving pralatrexate compared to the participants in the observation group.
Disease Status and/or Stage
Peripheral T-Cell Lymphoma
Sponsor
Allos Therapeutics
Key Eligibility
- Men and women age 18 and older
- Diagnosed with peripheral T-cell lymphoma (PTCL)
- Have completed at least 6 cycles of CHOP-based therapy
- Have achieved a complete or partial response following completion of CHOP therapy
- No prior therapy for PTCL other than the single CHOP regimen
- No previous treatment with pralatrexate
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Amelyn Rodriguez, RN
- (212) 746-1362
- [email protected]
- Weill Cornell Lymphoma Center
- (646) 962-2700
Protocol ID
PDX-017
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
