RecruitingPhase 1Phase 2NCT04047641

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))


Sponsor

M.D. Anderson Cancer Center

Enrollment

80 participants

Start Date

Oct 22, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of four drugs — cladribine, idarubicin, cytarabine (a standard chemotherapy), and quizartinib (a targeted drug for a mutation called FLT3) — for patients with acute myeloid leukemia (AML) or high-risk MDS (a bone marrow disorder that can become leukemia). Two groups are studied: newly diagnosed patients and those whose leukemia came back or didn't respond to treatment. **You may be eligible if...** - You have been diagnosed with AML or high-risk MDS (with more than 10% bone marrow blasts) - For the frontline group: You are 18-65 years old and have not received prior chemotherapy for AML/MDS - For the relapsed group: You are 18 or older and have received prior treatment that is no longer working - You are in reasonably good general health (ECOG performance 0-2) - Your kidneys and liver are functioning adequately **You may NOT be eligible if...** - You have a type of leukemia called acute promyelocytic leukemia (APL) - You have serious uncontrolled infections or significant organ problems - You have active central nervous system leukemia - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCladribine

Given Intravenous

DRUGCytarabine

Given Intravenous

DRUGIdarubicin

Given Intravenous

DRUGQuizartinib

Given by mouth


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04047641


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