Chemotherapy + Ponatinib + Blinatumomab for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Elias 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 trial tests a combination of low-intensity chemotherapy, ponatinib, and blinatumomab in patients with a specific type of leukemia that has returned or is not responding to treatment. Chemotherapy stops cancer cell growth, ponatinib blocks enzymes needed by cancer cells, and blinatumomab helps the immune system fight cancer. Blinatumomab is an immunotherapy that has shown significant improvement in overall survival for patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. The goal is to see if this combination works better for these patients.

Eligibility Criteria

Adults with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia, either untreated or resistant to treatment. Participants must be in good physical condition (ECOG <=2), have normal liver and kidney function, agree to use effective contraception, and not have a history of significant heart disease or other serious medical conditions.

Inclusion Criteria

I am 18 or older with a specific type of leukemia (Ph-positive ALL) that hasn't been treated yet.

I am 18 or older with a specific type of leukemia that has not responded to treatment.

Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome

Exclusion Criteria

I am not pregnant or breastfeeding and, if capable of becoming pregnant, will use birth control.

I have a serious infection that isn't getting better with antibiotics.

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

Participant Groups

The trial is testing the effectiveness of low-intensity chemotherapy combined with Ponatinib and Blinatumomab. It aims to see if this combination can stop cancer cells from growing by using different mechanisms including immune system modification.

Group I: Treatment (chemotherapy, ponatinib, blinatumomab) Experimental Treatment 9 Interventions

See Detailed Description.

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• High-risk first relapse BCP-ALL

🇺🇸 Approved in United States as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• First or second complete remission with minimal residual disease (MRD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References