Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 17, 2019

Primary Completion Date

September 30, 2021

Study Completion Date

December 31, 2023

Conditions
Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Myelodysplastic Syndrome
Interventions
DRUG

Azacitidine

Given IV

DRUG

Cytarabine

Given intrathecally and IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Methotrexate

Given intrathecally

DRUG

Pevonedistat

Given IV

DRUG

Therapeutic Hydrocortisone

Given intrathecally

Trial Locations (19)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

35233

Children's Hospital of Alabama, Birmingham

38105

Saint Jude Children's Research Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

60611

Lurie Children's Hospital-Chicago, Chicago

63110

Washington University School of Medicine, St Louis

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

80045

Children's Hospital Colorado, Aurora

92868

Children's Hospital of Orange County, Orange

94158

UCSF Medical Center-Mission Bay, San Francisco

98105

Seattle Children's Hospital, Seattle

02215

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Children's Oncology Group

NETWORK

lead

National Cancer Institute (NCI)

NIH

NCT03813147 - Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter