Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Acerta Pharma BV
Study ID
NCT03527147
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD9150 — DRUG
    AZD9150 will be administered as a 1-hour intravenous (IV) infusion on Days 1, 3, 5 of Cycle 1, followed by weekly infusions (starting Day 8 of Cycle 1 and beyond).
  • Acalabrutinib — DRUG
    Acalabrutinib will be administered orally twice daily (bid).
  • AZD6738 — DRUG
    AZD6738 will be administered orally twice daily (bid).
  • Hu5F9-G4 — DRUG
    HU5F9-G4 infusions will be given on Weekly (Day 1, 8, 15, and 22) during the first two 28-day cycles, then will be given every two weeks (Day 1 and Day 15) in Cycle 3 and beyond.
  • Rituximab — DRUG
    Rituximab infusions will be given Weekly starting on Day 8 (Day 8, 15, and 22) during the first 28-day cycle (4 weeks), then Day 1 of each 4 week cycle for Cycles 2-6. Starting with Cycle 8, Rituximab will be infused on Day 1 of every other cycle (every 8 weeks).
  • AZD5153 — DRUG
    AZD5153 will be administered orally once per day (qd).

Study Details

This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).

Key Dates

Start date
Jun 19, 2018
Status verified
Aug 2022
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD9150 + Acalabrutinib
    AZD9150 given in combination with acalabrutinib
  • Experimental: AZD6738 + Acalabrutinib
    AZD6738 in combination with acalabrutinib
  • Experimental: Hu5F9-G4 + rituximab + Acalabrutinib
    Hu5F9-G4/rituximab in combination with acalabrutinib
  • Experimental: AZD5153 + Acalabrutinib
    AZD5153 in combination with acalabrutinib

Primary Outcome Measure

Safety of the study treatments when given in combination [Incidence of adverse events] [ Time Frame: Through to study completion, an average of 1 year ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteSarasotaFlorida34232-
Research SiteAtlantaGeorgia30322-
Research SiteNew OrleansLouisiana70112-
Research SiteBethesdaMaryland20892-
Research SiteOmahaNebraska68198-
Research SiteRochesterNew York14642-
Research SiteNashvilleTennessee37203-
Research SiteCharlottesvilleVirginia22908-
Research SiteSeattleWashington98104-

Find similar trials in Los Angeles, CA

By research site
Research Site· Los Angeles, CAResearch Site· Sarasota, FLResearch Site· Atlanta, GAResearch Site· New Orleans, LAResearch Site· Bethesda, MDResearch Site· Omaha, NE

Related Studies