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NOT YET RECRUITING
NCT07691450
PHASE1

Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Phase 1 Investigation of Belinostat-Based Combinations in Relapsed/Refractory T-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2027-01-03

Completion Date

2029-11-24

Last Updated

2026-07-09

Healthy Volunteers

No

Conditions

Recurrent Anaplastic Large Cell LymphomaRecurrent Enteropathy-Associated T-Cell LymphomaRecurrent Follicular Helper T-Cell LymphomaRecurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypeRecurrent Follicular Helper T-Cell Lymphoma, Follicular-TypeRecurrent Follicular Helper T-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Hepatosplenic T-Cell LymphomaRecurrent Mature T-Cell and NK-Cell Non-Hodgkin LymphomaRecurrent Monomorphic Epitheliotropic Intestinal T-cell LymphomaRecurrent Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell LymphomaRecurrent Primary Cutaneous Gamma-Delta T-Cell LymphomaRecurrent Subcutaneous Panniculitis-Like T-Cell LymphomaRefractory Anaplastic Large Cell LymphomaRefractory Enteropathy-Associated T-Cell LymphomaRefractory Follicular Helper T-Cell LymphomaRefractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypeRefractory Follicular Helper T-Cell Lymphoma, Follicular-TypeRefractory Follicular Helper T-Cell Lymphoma, Not Otherwise SpecifiedRefractory Hepatosplenic T-Cell LymphomaRefractory Mature T-Cell and NK-Cell Non-Hodgkin LymphomaRefractory Monomorphic Epitheliotropic Intestinal T-cell LymphomaRefractory Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedRefractory Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell LymphomaRefractory Primary Cutaneous Gamma-Delta T-Cell LymphomaRefractory Subcutaneous Panniculitis-Like T-Cell Lymphoma

Interventions

DRUG

Azacitidine

Given SC

DRUG

Belinostat

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

OTHER

Fludeoxyglucose F-18

Given FDG

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Pralatrexate

Given SC

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

City of Hope Medical Center

Duarte, California, United States