A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo allogeneic HSCT
• Asparaginase Erwinia chrysanthemi — DRUG
  Given IM or IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo BM aspiration
• Bone Marrow Biopsy — PROCEDURE
  BM biopsy
• Computed Tomography — PROCEDURE
  Undergo CT
• Cytarabine — DRUG
  Given IV or IT
• Daunorubicin Hydrochloride — DRUG
  Given IV
• Dexrazoxane Hydrochloride — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Fludeoxyglucose F-18 — OTHER
  Undergo FDG-PET
• Gemtuzumab Ozogamicin — DRUG
  Given IV
• Gilteritinib Fumarate — DRUG
  Given PO/NG/G-tube
• Liposome-encapsulated Daunorubicin-Cytarabine — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Methotrexate — DRUG
  Given IT
• Mitoxantrone Hydrochloride — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo FDG-PET
• Questionnaire Administration — OTHER
  Ancillary studies
• Therapeutic Hydrocortisone — DRUG
  Given IT

Study Details

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Key Dates

Start date

Jul 21, 2020

Status verified

Feb 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

1,186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A High Risk Group
  Arm A High Risk Group: See Detailed Description.
• Experimental: Arm A Low Risk Group 1
  Arm A Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm A Low Risk Group 2
  Arm A Low Risk Group 2: See Detailed Description.
• Experimental: Arm AC High Risk Group
  Arm AC High Risk Group: See Detailed Description.
• Experimental: Arm AC Low Risk Group 2
  Arm AC Low Risk Group 2: See Detailed Description.
• Experimental: Arm AD High Risk Group
  Arm AD High Risk Group: See Detailed Description.
• Experimental: Arm AD Low Risk Group 2
  Arm AD Low Risk Group 2: See Detailed Description.
• Experimental: Arm B High Risk Group
  Arm B High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm B Low Risk Group 1
  Arm B Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm B Low Risk Group 2
  Arm B Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm BC High Risk Group
  Arm BC High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm BC Low Risk Group 2
  Arm BC Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm BD High Risk Group
  Arm BD High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)
• Experimental: Arm BD Low Risk Group 2
  Arm BD Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 3 years ]

Locations (185)

Find similar trials in Birmingham, AL

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