Health TrialsbyHealthPanel

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

ConditionPeripheral T Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcrotech Biopharma Inc.

About this trial

Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study.

Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to 6 cycles. The primary objective is to compare the Progression Free Survival of patients with newly diagnosed PTCL treated for up to 6 cycles with Beleodaq (belinostat) in combination with CHOP (Bel-CHOP) or Folotyn (pralatrexate injection) in combination with COP (Fol-COP) to CHOP alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Precursor T-cell lymphoma or leukemia

Adult T-cell lymphoma/leukemia

T-cell prolymphocytic leukemia

T-cell large granular lymphocytic leukemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belinostat Injection

    Drug

    Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle

  • Pralatrexate Injection

    Drug

    Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle

  • CHOP

    Drug

    CHOP is the comparator arm

  • COP

    Drug

    COP is given in combination with Pralatrexate

Treatment groups

504 Participants
are divided into 5 treatment groups
Group A: Group 1aActive comparator 2 interventions
Group B: Group 1bActive comparator 2 interventions
Group C: Group 2aActive comparator 2 interventions
Group D: Group 2bActive comparator 2 interventions
Group E: Group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival is determined from randomization to the first documented Progression of Disease or death, whichever occurs first.

Time frame
4.5 years

Secondary outcomes

1

Overall survival

It is the time from randomization to the death

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acrotech Biopharma Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now