A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Nordic Nanovector
Study ID
NCT01796171
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 10 MBq/kg Betalutin — DRUG
  • 15 MBq/kg Betalutin — DRUG
  • 20 MBq/kg Betalutin — DRUG
  • 40 mg lilotomab — DRUG
  • 100 mg/m2 lilotomab — DRUG
  • 60 mg/m2 lilotomab — DRUG
  • Rituximab — DRUG
  • 12.5 mBq/kg Betalutin — DRUG

Study Details

This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).

Key Dates

Start date
Dec 31, 2012
Status verified
Dec 2023
Primary completion
Oct 25, 2022
Completion
Oct 27, 2022

Study Design

Enrollment
191 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
  • Experimental: Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
  • Experimental: Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
  • Experimental: Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing
    10 MBq/kg (based on body weight) Betalutin without pre-dosing
  • Experimental: Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing
    15 MBq/kg (based on body weight) Betalutin without pre-dosing
  • Experimental: Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing
    15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing
  • Experimental: Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing
    15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
  • Experimental: Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing
    20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
  • Experimental: Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing
    20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing
  • Experimental: Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
  • Experimental: Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing
    20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
  • Experimental: Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
  • Experimental: Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing
    15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing

Primary Outcome Measure

Part A, Phase I [ Time Frame: 12 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
University Of Arkansas For Medical SciencesLittle RockArkansas72205-
Pacific Shores Medical GroupLong BeachCalifornia90813-
University of California, San Francisco (UCSF)San FranciscoCalifornia94143-
Boca Raton Regional HospitalBoca RatonFlorida33486-
Loyola University Medical CenterMaywoodIllinois60153-
Norton Cancer InstituteLouisvilleKentucky40207-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Stony Brook University Medical CenterStony BrookNew York11794-
Duke University Medical CenterDurhamNorth Carolina27710-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
West Penn HospitalPittsburghPennsylvania15224-
Baylor College of MedicineDallasTexas75246-

Find similar trials in Little Rock, AR

By research site
University Of Arkansas For Medical Sciences· Little Rock, ARPacific Shores Medical Group· Long Beach, CAUniversity of California, San Francisco (UCSF)· San Francisco, CABoca Raton Regional Hospital· Boca Raton, FLLoyola University Medical Center· Maywood, ILNorton Cancer Institute· Louisville, KY

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