City of Hope Medical Center
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.
PRIMARY OBJECTIVES: I. To evaluate the safety and feasibility of combining azacitidine with belinostat in R/R nodal TFH cell lymphoma. (Arm A) II. To evaluate the safety and feasibility of combining pralatrexate with belinostat in R/R PTCL and CTCL with large cell transformation. (Arm B) SECONDARY OBJECTIVES: I. To measure the clinical efficacy as measured by overall response rate (ORR), complete response (CR) rate, and time to next treatment (TTNT) of belinostat and azacitidine. (Arm A) II. Patient-reported outcomes as measured by the Patient-Reported Outcomes Measurement Information Syste…
Inclusion Criteria: * 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 * Histologically confirmed PTCL in the fo…
Given SC
Given IV
Undergo blood sample collection
Undergo CT or PET/CT
Undergo FDG-PET
Given FDG
Undergo PET/CT
Given SC
Ancillary studies