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

ConditionsAcute Myeloid LeukemiaBlasts 20 Percent or More of Bone Marrow Nucleated CellsHigh Risk Myelodysplastic SyndromeRecurrent Acute Biphenotypic LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent High Risk Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory High Risk Myelodysplastic Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results

Breastfeeding women

Patients with current active malignancies or any remission for < 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may be in remission for less than 6 months or have active disease

Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of >= 101 degrees Fahrenheit (F) for at least 48 hours (hrs) (before first dose, day 1)

Trial design

Design model

Single group

Treatments tested in this trial

  • Cladribine

    Drug

    Given Intravenous

  • Cytarabine

    Drug

    Given Intravenous

  • Idarubicin

    Drug

    Given Intravenous

  • Quizartinib

    Drug

    Given by mouth

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Treatment (idarubicin, cladribine, cytarabine, quizartinib)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Event free survival (EFS)

Will be estimate using the Kaplan-Meier method for each patient cohort. In addition, efficacy EFS will be analyzed in the intent to treat (ITT) population per cohort.

Time frame
From the date of start of treatment until event (resistance or relapse) or death, whichever occurred first, assessed up to 12 months
2

Incidence of adverse events

Defined as any clinically significant treatment-related grade 3 or greater non-hematologic toxicity. Patient toxicity data will be summarized using frequency and percentages, by type, grade and relationship to the study drugs.

Time frame
Up to 12 months

Secondary outcomes

1

Overall survival (OS)

Will be estimate using the Kaplan-Meier method for each patient cohort. In addition, efficacy OS will be analyzed in the ITT population per cohort.

Time frame
Up to 12 months
2

Disease free survival (DFS)

Will be estimate using the Kaplan-Meier method for each patient cohort. In addition, efficacy DFS will be analyzed in the ITT population per cohort.

Time frame
Up to 12 months
3

Rate of response

The rate of response will be estimated for each 28-gene panel of gene mutations for each patient cohort.

Time frame
Up to 12 months
4

Change of FLT3 ligand level

Will also explore the change of FLT3 ligand level before and after treatment using summary statistics, by patient cohort and by other subgroups (i.e. age).

Time frame
Baseline up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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