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NCT03598998 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
A Phase 1 study of Anaplastic Large Cell Lymphoma and Recurrent Follicular Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 3
- Study locations
NCT03598998: Active Phase 1 study of Anaplastic Large Cell Lymphoma and Recurrent Follicular Lymphoma, sponsored by City of Hope Medical Center.
NCT03598998 is a Phase 1 study of Anaplastic Large Cell Lymphoma and Recurrent Follicular Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 13 participants, below the 60-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598998, a Phase 1 study of Anaplastic Large Cell Lymphoma and Recurrent Follicular Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and pralatrexate may work better in treating patients with peripheral T-cell lymphomas.
Primary Outcome
Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Pralatrexate
Study Locations (3)
California
- City of Hope Medical Center - Duarte
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 1 |
What the registry record for NCT03598998 still lists
NCT03598998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (78% lower).
The record links to 10 conditions, with Anaplastic Large Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03598998 reports a single indexed study location in California, Georgia, Nebraska.
Frequently Asked Questions
What is clinical trial NCT03598998 about?
NCT03598998 is a clinical study titled "Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas". This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop t...
What is the current status of trial NCT03598998?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-02-04. Estimated completion is 2026-02-26.
What conditions does trial NCT03598998 study?
This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Mycosis Fungoides, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma.
What interventions are being tested in trial NCT03598998?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Pralatrexate (DRUG).
Who is sponsoring clinical trial NCT03598998?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598998 being conducted?
This trial has 3 study locations across California, Georgia, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03598998's enrollment target sits among peer trials
13 23rd of 25 higher than 3 of 25 other Anaplastic Large Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anaplastic Large Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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