Health Trials

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

ConditionsRecurrent 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
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Ability to understand and willingness to sign a written informed consent document

Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines

Age: ≥ 18 years

Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale (performance status [PS]) at time of enrollment. Patients with a performance status of 2 on the ECOG Scale due to lymphoma may be eligible with principal investigator (PI) approval

Disqualifiers

Patients who received prior therapy with belinostat or azacitidine (Arm A) or belinostat or pralatrexate (Arm B) without having had evidence of objective response (i.e. patients whose best response was stable disease or progressive disease)

Note: Patients who previously responded to any of these agents are eligible. Their last dose of either belinostat, azacitidine or pralatrexate must be > 14 days prior to day 1 of protocol therapy

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy

Prior autologous stem cell transplantation within 60 days of day 1 of protocol therapy

Trial design

Treatments tested in this trial

  • Azacitidine
  • Belinostat
  • Biospecimen Collection
  • Computed Tomography
  • FDG-Positron Emission Tomography
  • Fludeoxyglucose F-18
  • Positron Emission Tomography
  • Pralatrexate
  • Questionnaire Administration

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov