Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Public ClinicalTrials.gov record NCT07691450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1 Investigation of Belinostat-Based Combinations in Relapsed/Refractory T-Cell Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial tests the safety, side effects and best dose of azacitidine in combination with belinostat and how well the combination works in treating patients with follicular helper T cell lymphoma (TFH) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). This phase I trial also tests the safety, side effects and best dose of pralatrexate in combination with belinostat and how well the combination works in treating patients with relapsed or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) with large cell transformation and cytotoxic phenotype. Azacitidine stops cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of antimetabolite. Pralatrexate stops cells from using folic acid to make DNA. This may help keep cancer cells from growing and may kill them. Pralatrexate is a type of antimetabolite and a type of dihydrofolate reductase inhibitor. Belinostat blocks certain enzymes needed for cell division and may kill cancer cells. 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. It is a type of histone deacetylase inhibitor, a type of antiangiogenesis agent, and a type of chemosensitizer. Giving azacitidine in combination with belinostat may be safe, tolerable, and/or effective in treating patients with relapsed/refractory (R/R) TFH. In additional, giving pralatrexate in combination with belinostat may be safe, tolerable, and/or effective in treating patients with R/R PTCL and CTCL with large cell transformation and cytotoxic phenotype.
Study identification
- NCT ID
- NCT07691450
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 40 participants
Conditions and interventions
Conditions
- Recurrent Anaplastic Large Cell Lymphoma
- Recurrent Enteropathy-Associated T-Cell Lymphoma
- Recurrent Follicular Helper T-Cell Lymphoma
- Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
- Recurrent Follicular Helper T-Cell Lymphoma, Follicular-Type
- Recurrent Follicular Helper T-Cell Lymphoma, Not Otherwise Specified
- Recurrent Hepatosplenic T-Cell Lymphoma
- Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
- Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Recurrent Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma
- Recurrent Primary Cutaneous Gamma-Delta T-Cell Lymphoma
- Recurrent Subcutaneous Panniculitis-Like T-Cell Lymphoma
- Refractory Anaplastic Large Cell Lymphoma
- Refractory Enteropathy-Associated T-Cell Lymphoma
- Refractory Follicular Helper T-Cell Lymphoma
- Refractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
- Refractory Follicular Helper T-Cell Lymphoma, Follicular-Type
- Refractory Follicular Helper T-Cell Lymphoma, Not Otherwise Specified
- Refractory Hepatosplenic T-Cell Lymphoma
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Refractory Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
- Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Refractory Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma
- Refractory Primary Cutaneous Gamma-Delta T-Cell Lymphoma
- Refractory Subcutaneous Panniculitis-Like T-Cell Lymphoma
Interventions
- Azacitidine Drug
- Belinostat Drug
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- FDG-Positron Emission Tomography Procedure
- Fludeoxyglucose F-18 Other
- Positron Emission Tomography Procedure
- Pralatrexate Drug
- Questionnaire Administration Other
Drug · Procedure · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2, 2027
- Primary completion
- Nov 23, 2029
- Completion
- Nov 23, 2029
- Last update posted
- Jul 8, 2026
2027 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07691450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07691450 live on ClinicalTrials.gov.