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Flotetuzumab for Acute Myelogenous Leukemia
Study Summary
This trial is testing the side effects and best dose of flotetuzumab, an immunotherapy, for treating patients with recurrent or refractory acute myeloid leukemia.
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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- My condition did not improve after 2 or more chemotherapy cycles.I weigh at least 17 kilograms.I have a central line with two lumens installed for treatment.I have waited the required time after my radiation therapy before joining this trial.My condition has worsened or returned after treatment at least twice.I am not on any cancer treatments, except possibly hydroxyurea.I can care for myself but may not be able to do heavy physical work.It's been over 2 weeks since my last chemotherapy, and I've recovered from its side effects.I do not have any infections that are currently uncontrolled.It's been over 14 days since my last long-acting growth factor dose, or over 7 days for a short-acting one.I have received special chemotherapy to treat cancer in my brain or spinal cord before joining this study.My weight fits the current drug's formulation limits.My first relapse occurred after a stem cell transplant.It's been over 14 days since my last corticosteroid dose for immune side effects.I weigh at least 17 kilograms.My cancer has returned in the brain or outside the bone marrow only.I haven't taken any cancer medication that lowers blood counts in the last 7 days.It's been over 42 days since my last cell therapy or stem cell infusion, and I don't have GVHD.I have seizures but they are well controlled with medication.My leukemia is advanced, and I've had multiple treatments or a relapse after a stem cell transplant.You cannot be taking any other experimental drugs at the same time.I have recovered from previous cancer treatments and meet the required waiting period.My brain and spinal cord are mostly unaffected by my leukemia.It has been more than 42 days since my last radiopharmaceutical treatment.My current condition has no cure or treatment to extend life with good quality.I am taking medication for graft-versus-host disease after a bone marrow transplant.I have a genetic condition like Bloom syndrome or Fanconi anemia, but not Down syndrome.You have had a solid organ transplant in the past.It's been over 21 days since my last antibody treatment and any side effects are mild.I have a specific type of leukemia known as acute promyelocytic leukemia.I weigh more than 17 kg.I haven't taken steroids, except for replacement doses, for at least 7 days.My AML cancer has come back or is not responding to treatment, and this was confirmed by a lab test.My cancer has returned after not responding to the first chemotherapy.My kidney function is within the required range for my age and gender.I had CNS disease but now have no signs of it on scans.My hemoglobin level is at least 8.0 g/dL, possibly after a blood transfusion.My AML cancer has returned or is not responding to treatment, confirmed by tests.My side effects from previous treatments are mild, except for reflex issues.My bilirubin levels are within the normal range for my age.I can avoid driving or using heavy machinery while on flotetuzumab and for 30 days after.My platelet count is at least 20,000/mm^3.It has been over 21 days since my last treatment with interleukins, interferons, or cytokines.I have never been treated with flotetuzumab.I don't have brain-related symptoms or signs of leukemia in my nervous system.I have never been treated with CD123 targeted therapy.You are pregnant or nursing a baby.
- Group 1: Treatment (flotetuzumab, cytarabine)
- 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 measurable results is this clinical trial attempting to obtain?
"The main objective of this experiment, to be completed within a month's time frame, is to determine the dose-limiting toxicities caused by flotetuzumab. Secondary objectives include assessing the maximum concentration and area under the curve for plasma concentrations at steady state, as well as measuring anti-tumor activity through determining frequency and percentages of patients who experience partial responses."
What is the cap on participation in this research endeavor?
"This clinical trial has closed its recruitment period, initiating on June 1st 2020 and concluding most recently on October 7th 2022. If you're interested in other studies, there are 1466 trials searching for leukemic patients and 236 recruiting participants who hope to try Flotetuzumab."
Have any prior investigations utilized Flotetuzumab?
"At present, there are 236 active trials on Flotetuzumab with 60 in the third phase. These studies are primarily situated in New york City, though a total of 9791 sites worldwide have been used for testing this medication."
For which conditions is Flotetuzumab employed therapeutically?
"Flotetuzumab is a viable treatment option for leptomeningeal metastases, acute promyelocytic leukemia, and meningeal leukemia."
Are there various health centers conducting this research project in the city?
"This medical trail is running out of 19 different sites, including Children's National Medical Center in Washington D.C., Lurie Chidren's Hospital-Chicago in Chicago, Illinois, and Washington University School fo Medicine in Saint Louis Missouri."
Is participation in this experiment open to more volunteers?
"The posting on clinicaltrials.gov indicates that this particular medical trial is no longer enrolling patients. It was initially published on June 1st 2020 and since then has had its last update on October 7th 2022. Fortunately, there are currently 1702 other trials seeking participants at the moment."
Has Flotetuzumab been granted official authorization by the FDA?
"The level of safety associated with Flotetuzumab is currently rated at 1. This rating was assigned since the medication is in its initial trial phase, thus there are limited clinical studies validating both its efficacy and security."
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