Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 25, 2022

Primary Completion Date

June 13, 2024

Study Completion Date

February 28, 2027

Conditions
Refractory Acute Lymphoblastic LeukemiaRelapsed Acute Lymphoblastic Leukemia
Interventions
DRUG

Venetoclax

Given oral (PO).

DRUG

Navitoclax

Given oral (PO).

DRUG

Dexamethasone

Given orally (PO) or intravenously (IV).

DRUG

Vincristine

Given intravenously (IV).

DRUG

Calaspargase Pegol

Given intravenously (IV).

DRUG

Dasatinib

Given oral (PO).

DRUG

Cytarabine

Given intravenously (IV) or Intrathecal (IT).

BIOLOGICAL

Blinatumomab

Given intravenously (IV).

DRUG

Methotrexate

Given intravenously (IV), oral (PO), or Intrathecal (IT).

DRUG

Mercaptopurine

Given oral (PO).

DRUG

Cyclophosphamide

Given intravenously (IV).

DRUG

Etoposide

Given intravenously (IV).

DRUG

Leucovorin

Given oral (PO) or intravenously (IV).

DRUG

Intrathecal Triples

Given Intrathecal (IT).

DRUG

Pegaspargase

May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM).

DRUG

Erwinia asparaginase

To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).

RADIATION

Radiation

See detailed description section.

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

38105

St. Jude Children's Research Hospital, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER