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NCT05627245 · ClinicalTrials.gov registry record · Phase 1
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
A Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 11
- Study locations
NCT05627245: Active Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
NCT05627245 is a Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, above the 31-participant average among 20 other Recurrent Follicular Lymphoma trials with a reported enrollment target (55% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05627245, a Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of combination therapy with tazemetostat and belinostat in treating patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Tazemetostat is in a class of medications called EZH2 inhibitors. The EZH2 gene provides instructions for making a type of enzyme called histone methyltransferase which is involved in gene expression and cell division. Blocking EZH2 may help keep cancer cells from growing. Belinostat is in a class of medications called histone deacetylase inhibitors. Histone deacetylases are enzymes needed for cell division. Belinostat may kill cancer cells by blocking histone deacetylase. It may also prevent the growth of new blood vessels that tumors need to grow and may help make cancer cells easier to kill with other anticancer drugs. There is some evidence in animals and in living human cells that combination therapy with tazemetostat and belinostat can shrink or stabilize cancer, but it is not known whether this will happen in people. This trial may help doctors learn more about treatment of patients with relapsed or refractory lymphoma.
Primary Outcome
Defined as the highest dose level at which \< 33% of the dose cohort (0 of 3 or 1 of 6) experience a dose-limiting toxicity in the first cycle.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Belinostat
- OTHER Pharmacokinetic Study
Study Locations (11)
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Connecticut
- Yale University - New Haven
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What the registry record for NCT05627245 still lists
NCT05627245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, above the 31-participant average among 20 other Recurrent Follicular Lymphoma trials with a reported enrollment target (55% higher).
The record links to 10 conditions, with Recurrent Follicular Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05627245 lists 11 locations in 9 states (Kansas, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT05627245 about?
NCT05627245 is a clinical study titled "Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment". This phase I trial tests the safety, side effects, and best dose of combination therapy with tazemetostat and belinostat in treating patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Tazemetostat is in a class of me...
What is the current status of trial NCT05627245?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2023-03-01. Estimated completion is 2026-09-01.
What conditions does trial NCT05627245 study?
This clinical trial studies the following conditions: Recurrent Follicular Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory Follicular Lymphoma.
What interventions are being tested in trial NCT05627245?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Belinostat (DRUG), Pharmacokinetic Study (OTHER).
Who is sponsoring clinical trial NCT05627245?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627245 being conducted?
This trial has 11 study locations across California, Connecticut, Kansas, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Follicular Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05627245's enrollment target sits among peer trials
48 4th of 20 higher than 17 of 20 other Recurrent Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Follicular 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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