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

Summary

This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.

Conditions

• Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia
• ph+ 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.

Sponsors & Collaborators

• University of Chicago

  lead OTHER

Principal Investigators

• Wendy Stock, MD · University of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-02

Primary Completion

2027-03-01

Completion

2027-03-01

FDA Drug

Yes

Countries

• United States

Study Locations