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Tagraxofusp + Chemotherapy for Acute Lymphoblastic Leukemia
Study Summary
This trial is studying the effects of tagraxofusp combined with low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back or does not respond to treatment.
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.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with Philadelphia chromosome-positive ALL or Burkitt leukemia/lymphoma.I have taken a pregnancy test within the last week and it was negative.I am willing and able to follow the study's schedule and requirements.I have lasting side effects from past chemotherapy, but not hair loss, tiredness, or liver issues.My blood protein level is at least 3.2 g/dL without infusions.I do not have serious heart problems or uncontrolled high blood pressure.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with acceptable levels.I will use effective birth control during and for 4 months after the study.I am not pregnant or breastfeeding and, if capable of becoming pregnant, will use birth control during and for 4 months after the study. Men will also use birth control.I am 18-70 years old with a specific type of leukemia or lymphoma that tests positive for CD123.I can do most of my daily activities on my own.I have active leukemia in my brain or spinal cord.I am currently experiencing symptoms of graft versus host disease.I have a serious infection that isn't getting better with antibiotics.I do not have another cancer that is expected to shorten my life to under a year.I have hepatitis B, C, or HIV.My heart's pumping ability is below the normal range.I do not have severe lung problems that would make participating in the study risky.
- Group 1: Treatment (tagraxofusp, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What medical conditions can Tagraxofusp-erzs be administered to address?
"Tagraxofusp-erzs is largely employed to treat macular edema, but has also been used with success in cases of pheochromocytomas, eye inflammation and ulcerative colitis."
Is the eligibility criteria for this experiment inclusive of individuals over 30 years old?
"This trial is exclusively for individuals aged between 18 and 70. For younger patients, there are 1,243 clinical trials available; whereas those over 65 have access to 5,160 medical studies."
Are current enrollees being considered for this research project?
"Clinicaltrials.gov reveals that the trial is in full recruitment mode, with an original posting on February 17th 2022 and most recent update occurring July 10th of this year."
Are there any previous examples of trials utilizing Tagraxofusp-erzs?
"Presently, there are 2296 active clinical trials concerning Tagraxofusp-erzs with 531 of these studies in Phase 3. Several locations within Bethesda, Maryland are running research on this medicine; however, a total of 77905 sites around the world have launched their own versions of the trial."
What is the upper limit for participants in this medical research program?
"Indeed, the information on clinicaltrials.gov confirms that this medical study is actively seeking participants - it was first published on February 17th 2022 and most recently updated on July 10th 2022. 40 patients need to be found from one specific placement."
Am I eligible to take part in this scientific experiment?
"This investigation seeks to enroll 40 adults, aged 18-70, with precursor t-cell lymphoblastic leukemia-lymphoma. The selection criteria requires a performance status at or below 2 on the Eastern Cooperative Oncology Group (ECOG) scale and females of childbearing potential must provide documentation of a negative pregnancy test within seven days prior to beginning treatment."
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