Study on the Effectiveness of Belinostat or Pralatrexate Combined with CHOP Compared to CHOP Alone in Treating Peripheral T-Cell Lymphoma (PTCL)

Sponsor: Acrotech Biopharma Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06072131

Provider View

This clinical trial is testing whether adding Belinostat or Pralatrexate to the standard chemotherapy treatment CHOP can improve outcomes for patients with newly diagnosed Peripheral T-Cell Lymphoma (PTCL).

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 aims to find the best dose of Belinostat and Pralatrexate when combined with CHOP chemotherapy for patients with newly diagnosed PTCL. Part 2 will compare the effectiveness and safety of these combinations against CHOP alone in treating PTCL. Patients will be randomly assigned to one of three treatment groups and will receive up to six cycles of treatment. The main goal is to see if the new combinations can help patients live longer without the disease getting worse.

Description

This study is designed to test new treatment combinations for Peripheral T-Cell Lymphoma (PTCL). It has two parts:

Part 1: Dose Finding

  • This part of the study will test different doses of two drugs, Belinostat and Pralatrexate, combined with the standard chemotherapy regimen CHOP, which is used to treat PTCL. CHOP includes Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. The goal is to find the safest and most effective dose levels for these combinations.
  • Patients will be divided into five groups, each receiving a different treatment combination or dose level. The safety of these treatments will be closely monitored.

Part 2: Efficacy and Safety

  • In this part, patients with newly diagnosed PTCL will be randomly assigned to one of three treatment groups: Bel-CHOP, Fol-COP, or CHOP alone. The study will compare how well these treatments work in controlling the disease and their safety.
  • Each patient will receive up to six cycles of treatment, with each cycle lasting 21 days.
  • The study will track how long patients live without the disease getting worse and monitor any side effects.

Study Duration and Follow-Up

  • The study includes a screening period of up to 28 days, a treatment period of 18 weeks, and follow-up visits to monitor patients' health and disease status.
  • Tumor assessments will be conducted regularly to evaluate the treatment's effectiveness.

Patient Participation

  • Patients will need to provide a tumor sample for analysis and agree to follow the study's treatment and visit schedule.
  • The study will also include long-term follow-up to monitor overall survival and disease progression.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with Peripheral T-Cell Lymphoma (PTCL) and have not received any prior treatment.
  • Have a specific subtype of PTCL, such as Peripheral T-cell lymphoma, Angioimmunoblastic T-cell lymphoma, or others as defined by medical guidelines.
  • Have at least one measurable tumor site.
  • Be in good overall health with a performance status of 2 or lower, meaning able to carry out daily activities with some limitations.
  • Have adequate blood cell counts and organ function based on specific medical tests.
  • Be at least 18 years old.
  • Agree to use effective contraception during the study and for a period after the last treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Be willing to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Have a different type of T-cell lymphoma or leukemia not included in the study.
  • Currently taking certain medications that interfere with the study drugs.
  • Have another active cancer or life-threatening disease, except for certain non-threatening conditions.
  • Have previously received similar treatments like histone deacetylase inhibitors or pralatrexate.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have cancer that has spread to the brain or central nervous system.
  • Have a history of drug or alcohol abuse.
  • Are pregnant or breastfeeding.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.