Monoclonal Antibodies

Combination Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Houston, TX

Phase 2

Recruiting

Led By Elias Jabbour

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be ≥ 18 years of age with previously untreated Ph-positive ALL [either t(9;22) and/or BCR-ABL positive] or with lymphoid accelerated or blast phase CML

Participants must be ≥ 18 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML

Must not have

Active serious infection not controlled by oral or intravenous antibiotics

History of acute pancreatitis within 1 year of study or history of chronic pancreatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of immunotherapy and chemotherapy drugs to see if they are more effective than standard treatments for acute lymphoblastic leukemia.

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Who is the study for?

This trial is for adults with Philadelphia chromosome-positive or BCR-ABL positive acute lymphoblastic leukemia that's relapsed or resistant to treatment. Eligible participants must have acceptable liver and pancreas function, agree to contraception if of childbearing potential, and not be pregnant. They should not have serious infections, heart failure, uncontrolled cardiovascular disease, a history of significant bleeding disorders unrelated to cancer, active secondary malignancy expected to limit survival under one year, or CNS pathology.Check my eligibility

What is being tested?

The study tests the effectiveness of blinatumomab (an immunotherapy), methotrexate and cytarabine (chemotherapy drugs), combined with ponatinib (a drug blocking enzymes needed for cell growth) in treating patients with specific types of acute lymphoblastic leukemia. It aims to see how these treatments affect the immune system and cancer cell growth.See study design

What are the potential side effects?

Potential side effects include immune system changes leading to inflammation in various organs; reactions related to infusion; damage from chemotherapy such as nausea, hair loss, mouth sores; increased risk of infection; liver enzyme elevation due to ponatinib; fatigue; and possible impact on blood cells causing anemia or bleeding issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with untreated Ph-positive ALL or advanced CML.

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I am 18 or older with specific types of leukemia that have not responded to treatment.

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I am 18 or older with specific types of leukemia.

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I can take care of myself but might not be able to do heavy physical work.

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My liver is working well.

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I am of childbearing age and have a negative pregnancy test.

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I am a male and will use effective contraception or practice abstinence.

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My pancreas works well.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had pancreatitis within the last year or suffer from chronic pancreatitis.

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I do not have any active heart conditions.

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I have had a significant blood clot in my veins or arteries.

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I do not have an active HIV, HBV, or HCV infection.

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I have or had an autoimmune disease that could affect my brain or nerves.

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My high blood pressure is not under control.

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I have significant fluid buildup in my chest or around my heart.

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I have another cancer besides skin cancer.

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I have severe heart failure.

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I have a significant brain condition or event in my medical history.

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I have a history of serious bleeding problems not related to my cancer.

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I have very high triglyceride levels that aren't managed.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR) in relapsed/refractory ALL

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (blinatumomab, chemotherapy, ponatinib)Experimental Treatment4 Interventions

Patients receive blinatumomab IV nonstop on days 1-28 of cycles 1-5, and methotrexate and cytarabine intrathecally (by spinal tap) on days 1, 15, and 29 of cycles 1-4. Patients also receive ponatinib PO daily. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~4020

Methotrexate

2019

Completed Phase 4

~4400