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

Study acronym: CRESCENDO
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Trial sites reduced: 69 → 58 locations
    • Eligibility criteria expanded, about 48 words
    • Study description expanded, about 12 words
  2. Site details revised at 11 of 69 sitesv22
  3. Site contacts updated at 3 of 69 sitesv21
  4. Study sites: 67 to 69v20
  5. Study sites: 65 to 67v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 63 to 65v18
  2. Study sites: 60 to 63v17
  3. Study sites: 54 to 60v16
  4. Study sites: 52 to 54v15
  5. Study sites: 51 to 52v14
  6. Study sites: 28 to 51v13
  7. Study sites: 26 to 28
    • Eligibility criteria expanded, about 82 words
    v12
  8. Study sites: 20 to 26v11
  9. Study sites: 9 to 20v10
  10. Study sites: 4 to 9v9
  11. Study sites: 3 to 4v8
  12. Study sites: 2 to 3v7
  13. Study sites: 1 to 2v6
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Oct 4, 2023
    • Site details revised
    v5
  15. Re-verified, no change to tracked fieldsv4
  16. Study sites: 0 to 1v3
  17. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06072131
Lead Sponsor Acrotech Biopharma Inc.
Conditions
(from sponsor)		 Peripheral T Cell Lymphoma
Related terms Lymphoma, T-Cell, Peripheral
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov