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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azacitidine — DRUG
  Given SC
• Belinostat — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• FDG-Positron Emission Tomography — PROCEDURE
  Undergo FDG-PET
• Fludeoxyglucose F-18 — OTHER
  Given FDG
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Pralatrexate — DRUG
  Given SC
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

First listed

Jul 9, 2026

Start date

Jan 3, 2027

Status verified

Jul 2026

Primary completion

Nov 24, 2029

Completion

Nov 24, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (azacitidine, belinostat)
  Patients receive azacitidine SC on days 1-5 and belinostat IV over 30-45 minutes on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and FDG-PET, and CT or PET/CT throughout the study.
• Experimental: Arm B (pralatrexate, belinostat)
  Patients receive pralatrexate SC on days 8 and 15 and belinostat IV over 30-45 minutes on days 1-3 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and FDG-PET, and CT or PET/CT throughout the study.

Primary Outcome Measure

Occurrence of dose-limiting toxicities (DLT) (Arm A) [ Time Frame: Prior to cycle 2 day 1 (cycle length = 28 days) ]

Locations (1)

Find similar trials in Duarte, CA

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