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 range20 Years
SexALL
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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…
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