Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute M… (NCT02680951) | Clinical Trial Compass
WithdrawnPhase 1
Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia
Stopped: Withdrawn due to lack of participants.
0Started 2015-12
Plain-language summary
This study will examine the appropriate dose and side effects of dasatinib, when it is given with the standard of care chemotherapy for children and adolescents with Acute Myeloid Leukemia (AML).
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed relapsed or refractory Acute Myeloid Leukemia (AML) and meet the following criteria: Relapsed disease is defined as AML in 1st or greater marrow relapse; Refractory disease is defined as AML which failed to go into remission after 1st or greater relapse, OR AML which failed to go into remission after two or more induction attempts from original diagnosis
* ≥ 5% blasts by morphology in the bone marrow or molecular evidence of at least 0.1% leukemic blasts in the bone marrow
* Definitive evidence of t(8;21) or inv(16) by a CLIA approved cytogenetics laboratory from initial diagnosis
* CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy
* Lansky ≥ 50 for patients ≤ 16 years old; Karnofsky ≥ 50 for patients \> 16 years old
* Have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiation therapy prior to entering this study
* Have adequate renal and hepatic functions
* A shortening fraction greater than or equal to 27% by echocardiogram, OR ejection fraction greater than or equal to 50% by radionuclide angiogram (MUGA)
* Must not have any evidence of dyspnea at rest, exercise intolerance, and must have a pulse oximetry \> 94% at sea level
* Patients with a seizure disorder may be enrolled if well controlled on anticonvulsants at a dose that has been stable for at least 14 days
* Female participants of childbearing potential must have a n…
What they're measuring
1
Safety of Dasatinib assessed by the Number of Adverse Events