← Back to Search

Monoclonal Antibodies

Combination Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from documented complete response until relapse or death, assessed up to 6 years
Awards & highlights

Study 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.

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
Select...
I am 18 or older with untreated Ph-positive ALL or advanced CML.
Select...
I am 18 or older with specific types of leukemia that have not responded to treatment.
Select...
I am 18 or older with specific types of leukemia.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My liver is working well.
Select...
I am of childbearing age and have a negative pregnancy test.
Select...
I am a male and will use effective contraception or practice abstinence.
Select...
My pancreas works well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from documented complete response until relapse or death, assessed up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from documented complete response until relapse or death, assessed up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL)
Event-free survival
Overall response rate (ORR) in relapsed/refractory ALL
+2 more

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
~3310
Methotrexate
2013
Completed Phase 4
~3800
Blinatumomab
2014
Completed Phase 3
~1150
Ponatinib
2015
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,274 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,545 Total Patients Enrolled
AmgenIndustry Sponsor
1,361 Previous Clinical Trials
1,385,021 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03263572 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (blinatumomab, chemotherapy, ponatinib)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT03263572 — Phase 2
Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03263572 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of enrollment for this trial?

"Affirmative, information posted on clinicaltrials.gov confirms that this research endeavor is actively enlisting volunteers. This study was initially advertised in November 2017 and its most recent update occurred during the month of June 2022. The trial requires 90 participants to be sourced from a single medical centre."

Answered by AI

Are there any openings in this clinical experiment that require participation?

"As indicated on clinicaltrials.gov, this research is presently recruiting participants and was originally uploaded on November 29th 2017 with the most recent alteration being made on June 21st 2022."

Answered by AI

To what degree can Ponatinib be considered hazardous to those partaking in the treatment?

"Ponatinib's safety has been supported by preliminary data, so it was given a rating of 2. Unfortunately, there is currently no clinical research supporting its efficacy for this purpose."

Answered by AI

In what medical scenarios is Ponatinib often prescribed?

"Ponatinib is primarily used for liver transplantation, yet it can also provide relief from meningeal leukemia, small cell lung cancer (SCLC), and active pauciarticular juvenile rheumatoid arthritis."

Answered by AI
~19 spots leftby Nov 2025