Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

August 11, 2021

Study Completion Date

October 12, 2022

Conditions
Refractory Acute Lymphoblastic LeukemiaRelapsed Acute Lymphoblastic Leukemia
Interventions
DRUG

Pevonedistat

Administered each cycle on days 1, 3 and 5.

DRUG

Vincristine

Administered each cycle on days 2, 9, 16 and 23.

DRUG

Dexamethasone

Taken orally each cycle on days 2 through 15.

DRUG

PEG-asparaginase

Administered via intramuscular injection (IM) each cycle on days 9 and 23.

DRUG

Doxorubicin

Administered via IV each cycle on day 2.

DRUG

Cytarabine

Administered to all subjects via IT injection on day 1; and on days 9, 16, and 23 to CNS positive subjects.

DRUG

Methotrexate

Administered via IT injection to CNS negative subjects on day 16; and to CNS positive subjects on days 9, 16 and 23.

DRUG

Hydrocortisone

Administered via IT injection to CNS positive subjects on days 9, 16, and 23.

Trial Locations (1)

33136

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Julio Barredo, MD

OTHER