A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT04075747
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CPX-351 — DRUG
    Up to 2 induction and 2 consolidation courses will be offered
  • Venetoclax — DRUG
    Will be administered over specified duration during induction and consolidation courses
  • Midostaurin — DRUG
    Will be administered over specified duration during induction and consolidation courses
  • Enasidenib — DRUG
    Will be administered over specified duration during induction and consolidation courses

Study Details

JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.

Key Dates

Start date
Dec 2, 2019
Status verified
Oct 2023
Primary completion
Feb 7, 2022
Completion
Sep 12, 2023

Study Design

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

Arms

  • Experimental: Arm A
  • Experimental: Arm B
  • Experimental: Arm C

Primary Outcome Measure

Determine the Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 30 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Stanford University School of Medicine- Standford Cancer InstitutePalo AltoCalifornia94305-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
University of Kansas Cancer CenterFairwayKansas66205-
Johns Hopkins UniversityBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
University of Nebraska Medical CenterOmahaNebraska68105-
Hackensack University Medical CenterHackensackNew Jersey07601-
Duke UniversityDurhamNorth Carolina27710-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CAStanford University School of Medicine- Standford Cancer Institute· Palo Alto, CAGeorgia Cancer Center at Augusta University· Augusta, GAUniversity of Kansas Cancer Center· Fairway, KSJohns Hopkins University· Baltimore, MDMassachusetts General Hospital· Boston, MA

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