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

Part of paid clinical trials in Clovis, California.

Sponsor
Acrotech Biopharma Inc.
Study ID
NCT06072131
Phase
PHASE3
Status
Recruiting
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Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Oct 2025
Primary completion
Jul 31, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
504 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1a
    Group 1a Belinostat 600 mg/m2 + CHOP
  • Active Comparator: Group 1b
    Group 1b Belinostat 1000 mg/m2 + CHOP
  • Active Comparator: Group 2a
    Group 2a Pralatrexate 20 mg/m2 + COP
  • Active Comparator: Group 2b
    Group 2b Pralatrexate 30 mg/m2 + COP
  • Active Comparator: Group 3
    CHOP

Primary Outcome Measure

PFS [ Time Frame: 4.5 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, San Francisco FresnoClovisCalifornia93611
Joseph Mosholder
[email protected]
Richard Ward
[email protected]
5593871828
Haifaa Abdulhaq, MD (PRINCIPAL_INVESTIGATOR)
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600Santa MonicaCalifornia90404
Marvin Valencia
[email protected]
310-633-8400
Rosa Bishop
[email protected]
Herbert Eradat, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado School of MedicineAuroraColorado80045
Bradley Haverkos, MD
[email protected]
303-724-7770
Bradley Haverkos, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer InstitutePembroke PinesFlorida33026
Andres Alvarez
[email protected]
954-265-4325
Jose Sandoval Sus, MD (PRINCIPAL_INVESTIGATOR)
Norton Cancer InstituteLouisvilleKentucky40207
Jason Beare
[email protected]
502-629-5756
Don Stevens, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
JAWAD Z SHEQWARA, MD
[email protected]
JAWAD Z SHEQWARA, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Kassie DiOrio
[email protected]
732-235-2135
Joanna Rhodes, MD (PRINCIPAL_INVESTIGATOR)
Valley Cancer AssociatesHarlingenTexas78550-
Houston Methodist HospitalHoustonTexas77030
Danielle Sewall
[email protected]
Christine Cong
Ravi Pingali, MD (PRINCIPAL_INVESTIGATOR)
University of Texas, MD Anderson Cancer CenterHoustonTexas77030
Vaishnavi Vutukuri
[email protected]
713-792-5242
Swaminathan P Iyer, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Medical Center - TempleTempleTexas76508
Lorie Fares
[email protected]
254-724-1395
Archana Sagar, MD (PRINCIPAL_INVESTIGATOR)

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University of California, San Francisco Fresno· Clovis, CAUniversity of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600· Santa Monica, CAUniversity of Colorado School of Medicine· Aurora, COMoffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute· Pembroke Pines, FLNorton Cancer Institute· Louisville, KYHenry Ford Health System· Detroit, MI

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