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Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

ConditionsAcute Biphenotypic LeukemiaAcute Myeloid LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlasts 10 Percent or More of Bone Marrow Nucleated CellsBlasts 10 Percent or More of Peripheral Blood White Cellsde Novo Myelodysplastic SyndromeMyelodysplastic SyndromePreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Acute Myeloid LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveSecondary Acute Myeloid LeukemiaUntreated Adult Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (>/= 10% blasts or IPSS >/= intermediate-2) will be eligible. Patients with CML in Myeloid Blast Phase are also eligible.

For Frontline cohort (1 or 4): No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.

For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.

Age </= 65 years.

Disqualifiers

Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.

Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patient with documented hypersensitivity to any of the components of the chemotherapy program.

Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cladribine

    Drug

    Given IV

  • Cytarabine

    Drug

    Given IV

  • Gilteritinib

    Drug

    Given PO

  • Idarubicin

    Drug

    Given IV

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Midostaurin

    Drug

    Given PO

  • Venetoclax

    Drug

    Given PO

Treatment groups

508 Participants
are divided into 1 treatment group
Group A: Treatment (cladribine, cytarabine, idarubicin)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR) rate

CR rate will be determined.

Time frame
Up to 12 months

Secondary outcomes

1

Overall response rate (ORR)

ORR will be determined.

Time frame
Up to 12 months
2

Overall survival (OS)

OS will be assessed.

Time frame
Up to 12 months
3

Event-free survival (EFS)

EFS will be assessed.

Time frame
Up to 12 months
4

Duration of response

Duration of response will be assessed.

Time frame
Up to 12 months

Other outcomes

1

Use of intrathecal prophylaxis

The relationship between patient/disease characteristics and use of intrathecal prophylaxis will be studied and described.

Time frame
Up to 12 months
2

Incidence of leptomeningeal disease

The relationship between patient/disease characteristics and incidence of leptomeningeal disease will be studied and described.

Time frame
Up to 12 months

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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