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Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Sep 1, 2026 → Jun 1, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 81 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 1, 2026 to Jun 1, 2027 Secondary endpoints: details revised at 4 of 10 entries · Study description revised · Site details revised at 2 of 11 sites · 1 more Show 4 more changesShow less
    • Secondary endpoints: details revised at 4 of 10 entries
    • Study description revised
    • Site details revised at 2 of 11 sites
    • Eligibility criteria expanded, about 5 words
  2. 22 versions Re-verified since Mar 13, 2026, no change to tracked fieldsv59-v80
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 11 of 11 sitesv58 Show 1 more changeShow less
    • Site details revised at 11 of 11 sites
  4. 20 versions Re-verified since Sep 2, 2025, no change to tracked fieldsv38-v57
  5. Study sites: 10 to 11v37
Show 5 earlier versionsHide 5 earlier versions
  1. Site contacts updated at 1 of 10 sitesv36
  2. Study sites revised (10)v35 See this version in full on ClinicalTrials.gov ↗
  3. Site contacts updated at 1 of 10 sitesv34
  4. Trial status: Suspended to Recruiting Enrollment target: 64 to 48v33 Show 1 more changeShow less
    • Enrollment target: 64 to 48
  5. Interventions: Belinostat (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Pharmacokinetic Study (Other)… to Belinostat (Drug), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Pharmacokinetic Study…v32
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05627245
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Follicular Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma +6 more
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov