Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2027

Conditions
Lymphoblastic LeukemiaAcute Lymphoblastic Leukemiaph+ Acute Lymphoblastic Leukemia
Interventions
DRUG

Inotuzumab ozogamicin

Inotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

DRUG

Dasatinib

Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

DRUG

Dexamethasone

Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.

DRUG

Methotrexate

Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.

DRUG

Vincristine

Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat various types of cancer such as acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others.

DRUG

Ponatinib

A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors. It is also being studied in the treatment of other types of cancer. Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.

DRUG

Methotrexate for Injection

Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia. When given intrathecally, it prevents leukemia cells entering the cerebrospinal fluid (CSF) around the spine and brain. Intrathecal chemotherapy is administered during a procedure called a lumbar puncture or through an ommaya reservoir (shunt).

PROCEDURE

Allogenic Stem Cell Transplantation

A procedure in which a patient receives healthy blood-forming cells (stem cells) from a donor to replace their own stem cells that have been destroyed by treatment with radiation or high doses of chemotherapy. In an allogeneic stem cell transplant, the healthy stem cells may come from the blood or bone marrow of a related donor who is not an identical twin of the patient or from an unrelated donor who is genetically similar to the patient. An allogeneic stem cell transplant is most often used to treat blood cancers, such as leukemia and lymphoma, and certain types of blood or immune system disorders.

Trial Locations (1)

60615

RECRUITING

University of Chicago Medical Center, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER