Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
MEI Pharma, Inc.
Study ID
NCT04745832
Phase
PHASE3
Status
Terminated

Conditions

  • Follicular Lymphoma (FL)
  • Marginal Zone Lymphoma
  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Zandelisib — DRUG
    Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
  • Rituximab — DRUG
    Rituximab IV 375 mg/m2 for 6 cycles
  • Bendamustine — DRUG
    Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
  • CHOP — DRUG
    Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Study Details

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Key Dates

Start date
Aug 13, 2021
Status verified
Dec 2022
Primary completion
Mar 20, 2023
Completion
Mar 20, 2023

Study Design

Enrollment
82 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab plus Zandelisib
    Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles
  • Experimental: Rituximab plus chemotherapy
    Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles

Primary Outcome Measure

Progression Free Survival [ Time Frame: 1 year 7 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
The Oncology Institute of Hope and InnovationTucsonArizona85745-
Orange Coast Memorial Medical CenterFountain ValleyCalifornia92708-
Long Beach Memorial Medical CenterLong BeachCalifornia90806-
The Oncology Institute of Hope and InnovationRiversideCalifornia92506-
BRCR Medical Center IncHollywoodFlorida33021-
Henry Ford HospitalDetroitMichigan48202-
Revive Research InstituteFarmington HillsMichigan48334-
Revive Research InstituteSterling HeightsMichigan48314-
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer CenterSpringfieldMissouri65804-
Inspira Medical Center Mullica HillMullica HillNew Jersey08062-
MetroHealth Medical CenterClevelandOhio44109-
Alpha Research Institute, LLCBaytownTexas77521-
Valley Cancer AssociatesHarlingenTexas78550-
Community Cancer Trials of UtahOgdenUtah84405-

Find similar trials in Tucson, AZ

By research site
The Oncology Institute of Hope and Innovation· Tucson, AZOrange Coast Memorial Medical Center· Fountain Valley, CALong Beach Memorial Medical Center· Long Beach, CAThe Oncology Institute of Hope and Innovation· Riverside, CABRCR Medical Center Inc· Hollywood, FLHenry Ford Hospital· Detroit, MI

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