CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 14, 2018

Primary Completion Date

November 27, 2021

Study Completion Date

March 25, 2027

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

CPX-351

-CPX-351 will be provided by Jazz Pharmaceuticals

PROCEDURE

Research skin biopsy

"-And/or buccal swab~* Pre-treatment~* Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)"

PROCEDURE

Research blood draw

"* Pre-treatment~* Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)~* Post-consolidation 1 (if applicable)~* Post-consolidation 2 (if applicable)~* Post-transplant Day 30 (if applicable)~* Post-transplant Day 100 (if applicable)"

PROCEDURE

Research bone marrow aspirate

"* Pre-treatment~* Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)~* Post-consolidation 1 (if applicable)~* Post-consolidation 2 (if applicable)~* Post-transplant Day 30 (if applicable)~* Post-transplant Day 100 (if applicable)"

Trial Locations (3)

33612

Moffitt Cancer Center, Tampa

63110

Washington University School of Medicine, St Louis

98109

Fred Hutchinson Cancer Research Center, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Washington University School of Medicine

OTHER