Chemotherapy + Ponatinib for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Elias Jabbour | MD Anderson Cancer Center

Overseen byElias Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.

Eligibility Criteria

This trial is for patients with untreated or previously treated Ph-positive acute lymphoblastic leukemia (ALL) or chronic myelogenous leukemia (CML) in blast phase. Participants must be physically able to perform daily activities with minimal assistance, have normal organ function, and agree to use effective contraception. Excluded are those with serious infections, active hepatitis B, severe heart conditions, uncontrolled blood pressure, a history of significant bleeding disorders unrelated to cancer, or alcohol abuse.

Inclusion Criteria

Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome

Alanine aminotransferase (ALT) =< 2 x ULN

Aspartate aminotransferase (AST) =< 2.5 x ULN

+8 more

Exclusion Criteria

I have active hepatitis B but am on treatment to control it.

I have another cancer besides skin cancer that may shorten my life to under a year.

I do not have severe heart failure.

+10 more

Participant Groups

The study tests how well a combination of chemotherapy drugs like cyclophosphamide and doxorubicin hydrochloride works alongside ponatinib hydrochloride—a drug that blocks enzymes needed for cancer cell growth—in treating ALL. It's a phase II trial aiming to determine the effectiveness and side effects of this treatment regimen.

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy, ponatinib hydrochloride)Experimental Treatment13 Interventions

See Detailed Description.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: