Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Re… (NCT04047641) | Clinical Trial Compass
RecruitingPhase 1/2
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
United States80 participantsStarted 2019-10-22
Plain-language summary
This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.
Who can participate
Age range18 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:
* Diagnosis of
* AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts, excluding Acute promyelocytic leukemia),
* Acute biphenotypic leukemia or
* High-risk MDS (\> 10% bone marrow blasts)
* Frontline cohort: Patients aged 18 to 65 years
* Relapse cohort: Patients aged \>=18 years old
* Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:
* For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \[Hydrea\] \[no dose limit\], tretinoin \[atra\] \[no dose limit\] or ara-C \[one or two doses (max 2 gr/m\^2 per dose)\] for transient control of hyperleukocytosis) for AML or MDS. They may have received hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or Hydrea are allowed
* For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\> 10% bone marrow blasts)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Creatinine \< 1.5 mg/dl
* Total bilirubin \< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
* Transaminases (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN)
* Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limi…
What they're measuring
1
Event free survival (EFS)
Timeframe: From the date of start of treatment until event (resistance or relapse) or death, whichever occurred first, assessed up to 12 months