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Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing a new chemotherapy treatment for leukemia that includes an immunotherapy drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 111 Patients • NCT02393859Trial Design
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- My bone marrow sample will be tested for minimal residual disease.I can care for myself but may not be able to do heavy physical work.I am between 30 and 70 years old.My leukemia diagnosis was confirmed through specific blood tests.My tests show I do not have the Philadelphia chromosome in my cancer cells.I have been HLA typed or have a valid reason for not being.I can care for myself after initial cancer treatment.My cancer responded completely to the initial treatment.I can care for myself and am up and about more than 50% of my waking hours.My blood tests show I am in remission from cancer.I have recovered from any serious infections caused by previous treatments.My bilirubin levels are less than 1.5 times the upper limit.My samples will be tested for specific cancer markers by a designated lab.I do not have Burkitt's-like leukemia and had a bone marrow test within the last week.I do not have any major health issues that could affect my treatment.I do not have any significant brain or nervous system conditions.I do not have any current infections that aren't under control.I can care for myself but may not be able to do heavy physical work.My kidney function, measured by creatinine, is within the normal range.I have recovered from any serious infections after my initial cancer treatment.My blood tests show I am currently in remission.I have recovered from any serious infections caused by my cancer treatments.I am not currently being treated for another cancer.I have never had a blood disorder before.
- Group 1: Arm II (chemotherapy)
- Group 2: Arm I (blinatumomab, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA given Blinatumomab the green light?
"There is some evidence, from both this Phase 3 trial and others, that Blinatumomab is effective and safe."
Is this research project only looking for participants who are under 40 years old?
"The ideal participants for this study will be between the ages of 30 and 70."
Could I inquire about the requirements to take part in this research project?
"This trial is looking for 488 patients aged between 30 and 70 that have been diagnosed with acute lymphoblastic leukemia. Most notably, applicants are required to meet the following criteria: PRE-REGISTRATION, Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution, INDUCTION ELIGIBILITY CR"
Are people with this condition still able to join the research project?
"According to the most recent update on clinicaltrials.gov, this particular trial is not currently looking for participants. It was initially posted on December 23rd, 2013 but was last updated on September 15th, 2022. Although this study is not presently recruiting, there are 3,816 other trials that are."
Is Blinatumomab a new drug on the market?
"Blinatumomab has a long clinical history, with the first study being conducted in 1993 at the National Institutes of Health Clinical Center. There have been a total of 4524 completed studies on this medication. Additionally, there are 2273 clinical trials actively recruiting patients which are located in many places, including Anaconda, Montana."
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