A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

Part of paid clinical trials in Duarte, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT04038437
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CPX-351 — DRUG
    CPX-351 will be administered on Days 1 and 3 of each cycle
  • Venetoclax — DRUG
    Venetoclax will be adminstered on Days 2 to 21 of each cycle

Study Details

Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT) and to determine the recommended phase 2 dose (RP2D) for the Expansion Phase. This study will comprise 2 phases: a Dose Exploration Phase (Part 1) and an Expansion Phase (Part 2), in which all subjects will receive a combination of CPX-351 and venetoclax.

Key Dates

Start date
Oct 15, 2019
Status verified
Nov 2022
Primary completion
Apr 26, 2022
Completion
Sep 24, 2022

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CPX-351 and Venetoclax
    CPX-351 and Venetoclax will be administered over 28 day cycles

Primary Outcome Measure

Maximum Tolerated Dose (MTD) as determined by the specified dose exploration [ Time Frame: Up to 36 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Blood & Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-
University of Kansas Medical CenterKansas CityKansas66160-
Dana Farber/ Brigham & Women's Cancer CenterBostonMassachusetts02215-
Washington University School of MedicineSt LouisMissouri63110-
Oregon Health & Science UniversityPortlandOregon97239-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CABlood & Marrow Transplant Group of Georgia· Atlanta, GAUniversity of Kansas Medical Center· Kansas City, KSDana Farber/ Brigham & Women's Cancer Center· Boston, MAWashington University School of Medicine· St Louis, MOOregon Health & Science University· Portland, OR

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