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Evaluating Belinostat or Pralatrexate with CHOP for Peripheral T Cell Lymphoma

A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Phase 3 Interventional Acrotech Biopharma Inc. · NCT06072131

This study is testing if adding two new drugs, Belinostat and Pralatrexate, to the standard CHOP treatment can help people with newly diagnosed Peripheral T Cell Lymphoma live longer without their cancer getting worse.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment504 (estimated)
Ages18 Years and up
SexAll
SponsorAcrotech Biopharma Inc. Industry-sponsored
Drugs / interventionsBrentuximab, chemotherapy, Cyclophosphamide, Doxorubicin, Prednisone
Locations69 sites (Clovis, California and 68 other locations)
Trial IDNCT06072131 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Belinostat and Pralatrexate in combination with the CHOP regimen for patients with newly diagnosed Peripheral T Cell Lymphoma (PTCL). The study is divided into two parts: the first part focuses on dose finding for the investigational drugs, while the second part assesses the effectiveness of the selected doses compared to CHOP alone. Patients will be randomized into three treatment groups and receive treatment for up to six cycles. The primary goal is to compare the progression-free survival rates among the different treatment arms.

Who should consider this trial

Good fit: Ideal candidates are patients with newly diagnosed, untreated histology-proven PTCL who meet specific eligibility criteria.

Not a fit: Patients with previously treated PTCL or those who are not eligible for the investigational drugs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with newly diagnosed PTCL.

How similar studies have performed: Other studies have shown promise in using combination therapies for PTCL, but this specific approach is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:

   1. Pathology subtype:

      * Peripheral T-cell lymphoma, not otherwise specified
      * Angioimmunoblastic T-cell lymphoma
      * Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.
      * Follicular T-cell lymphoma
      * Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma
   2. CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation.
2. Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3)
3. Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2
4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:

   1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement
   2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement
   3. Total bilirubin ≤1.5 mg/dL
   4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)
   5. Calculated creatinine clearance of ≥ 60 mL/min
5. Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions:

   1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement
   2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement
   3. Total bilirubin ≤1.5 mg/dL
   4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)
   5. Calculated creatinine clearance of ≥ 60 mL/min
6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation.
7. Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements
8. Patient (male or female) is at least 18 years of age at the time of informed consent
9. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment.
10. Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.

Exclusion Criteria:

A patient will not be eligible for inclusion if ANY of the criteria listed below apply:

1. Patients with a diagnosis of:

   1. Precursor T-cell lymphoma or leukemia
   2. Adult T-cell lymphoma/leukemia
   3. T-cell prolymphocytic leukemia
   4. T-cell large granular lymphocytic leukemia
   5. Primary cutaneous type ALCL
   6. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)
   7. ALCL if they can be treated with Brentuximab Vedotin (BV)
2. Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat
3. Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years
4. Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy
5. Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (i.e. demonstration of a QTc interval \>450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes
6. Patient with uncontrolled hypertension
7. Patients status on the following:

   1. Has a known HIV-positive diagnosis with uncontrolled and detectable viral load
   2. Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease
8. Patient with central nervous system metastasis
9. Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment
10. Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study
11. Patient with a known history of drug or alcohol abuse
12. Pregnant or breastfeeding women

Where this trial is running

Clovis, California and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral T Cell Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.