Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia (NCT04158739) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia
United States16 participantsStarted 2020-01-22
Plain-language summary
This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory). This study also determines the safest dose of flotetuzumab to use in children with AML. As an immunotherapy, flotetuzumab may also cause changes in the body's normal immune system, which are also under study in this trial.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must weigh \>/= 17 kg
* Weight limit is due to constraints related to the concentration of the current drug formulation. If a new formulation of flotetuzumab becomes available to allow dosing of smaller patients, the protocol will be amended.
* Patients with recurrent or refractory AML are eligible. Patients must have histologic verification of malignancy at relapse.
* Patients with leukemia must have \>/= M2 marrow by morphology and/or flow cytometry and one of the following:
* Second or greater relapse
* Refractory after 2 or more chemotherapy cycles
* First relapse after primary chemotherapy-refractory disease
* First relapse after hematopoietic stem cell transplantation (HSCT)
* Central nervous system (CNS) disease:
* Patients must have the status of CNS1 and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsy.
* Patients with CNS3 or CNS2 status may receive antecedent intrathecal chemotherapy to achieve CNS1 status prior to study entry.
* Patients with a history of CNS chloromatous disease are required to have no radiographic evidence of disease prior to enrollment.
* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \> 16 y…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicities Due to Flotetuzumab
Timeframe: Up to 29 days
2
Maximum Tolerated Dose or Recommended Phase 2 Dose of Flotetuzumab