- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326439
AflacLL1901 (CHOA-AML)
CHOA-AML: A Pilot Study for Newly Diagnosed Pediatric Patients With Acute Myeloid Leukemia (AML)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Egleston Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: Patients must be less than 21 years of age at the time of study enrollment
- Diagnosis: Patients must be newly diagnosed with AML
- Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2016 WHO Myeloid Neoplasm Classification are eligible.
- Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive. In cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis.
Patients with <20% bone marrow blasts are eligible if they have:
- A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities,
- the unequivocal presence of megakaryoblasts, or
- Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
- Performance Level: Patients with acceptable organ function and any performance status are eligible for enrollment
Exclusion Criteria:
Patients with any of the following constitutional conditions are not eligible:
- Fanconi anemia
- Shwachman syndrome
- Any other known bone marrow failure syndrome
- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Note: Enrollment may occur, pending results of clinically indicated studies to exclude these conditions.
Other Excluded Conditions:
- Any concurrent malignancy
- Juvenile myelomonocytic leukemia (JMML)
- Philadelphia chromosome positive AML
- Biphenotypic or bilineal acute leukemia
- Acute promyelocytic leukemia (APL)
- Acute myeloid leukemia arising from myelodysplasia
- Therapy-related myeloid neoplasms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aflac-AML Regimen for Low Risk AML Patients
Participants in this arm will receive the standard Aflac-AML Regimen with the following chemotherapy:
Patients with low risk status who had low risk markers and were MRD positive at the end of Induction I and continue to be MRD positive after Induction II will come off protocol. |
100 mg/m²/dose every 12 hours IV Days 1-10
Other Names:
50 mg/m²/dose IV Days 1, 3, 5
Other Names:
25,000 International Units/m²/dose IM Days 2, 9
Other Names:
150 mg/m²/dose IV Days 1-5
Other Names:
Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.
Other Names:
|
Experimental: Aflac-AML Regimen for High Risk AML Patients
Participants in this arm will receive standard Aflac-AML Regimen with the following chemotherapy:
If a patient is classified as High risk after Induction I, they may proceed to best allogenic donor SCT following Induction II. These patients may receive a third course of chemotherapy prior to HSCT. In cases where HSCT is not an option, patients can receive 4 cycles of chemotherapy. Only patients with FLT3-ITD mutation will receive sorafenib. |
100 mg/m²/dose every 12 hours IV Days 1-10
Other Names:
50 mg/m²/dose IV Days 1, 3, 5
Other Names:
25,000 International Units/m²/dose IM Days 2, 9
Other Names:
150 mg/m²/dose IV Days 1-5
Other Names:
Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.
Other Names:
Transplantation of multipotent hematopoietic stem cells from bone marrow
Other Names:
200 mg/m2/dose daily, rounded to accommodate tablet size.
The maximum dose will be 400 mg.
Days 7 through 34.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free Survival (EFS) in Low Risk Patients and High Risk Patients
Time Frame: Up to 2 years post-intervention
|
Event-free survival defined as the time from on study to death, failure to achieve remission or relapse in newly diagnosed patients with pediatric acute myeloid leukemia in the Low risk stratification group and High risk stratification group
|
Up to 2 years post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to 2 years post-intervention
|
Time from study entry and from end of first course of therapy for newly diagnosed patients with pediatric acute myeloid leukemia
|
Up to 2 years post-intervention
|
Minimal Residual Disease (MRD) Negative Status
Time Frame: Post-induction I, an average of 28 days
|
Number of patients that are in remission (MRD negative) after course 1 in participants receiving GO and those that did not receive GO.
|
Post-induction I, an average of 28 days
|
Disease-free Survival (DFS) for Patients Who Are MRD Negative
Time Frame: Up to 2 years post-intervention
|
Disease-free survival for patients who are MRD negative but lack high or low risk molecular and cytogenetic features, defined as time from end of first course of therapy to death or relapse
|
Up to 2 years post-intervention
|
Cardiotoxicity in Patients With de Novo AML That Receive the Four-cycle Aflac-AML Regimen With the Inclusion of Dexrazoxane
Time Frame: At completion of Cycle 4 (each cycle average is 28 days)
|
Number of patients that develop cardiac ejection fraction <50% (CTCAE V5.0 grade 2 or greater dysfunction) either during therapy (early cardiotoxicity) or after completion of therapy (late cardiotoxicity)
|
At completion of Cycle 4 (each cycle average is 28 days)
|
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Time Frame: At the end of each cycle (each cycle average is 28 days)
|
Number of participants that developed infection and/or febrile neutropenia at the end of each treatment cycle.
|
At the end of each cycle (each cycle average is 28 days)
|
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Time Frame: At the end of each cycle (each cycle average is 28 days)
|
Duration of hospital admission in patients that developed infection and febrile neutropenia at the end of each treatment cycle
|
At the end of each cycle (each cycle average is 28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Himalee Sabnis, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Antibiotics, Antineoplastic
- Etoposide
- Sorafenib
- Cytarabine
- Daunorubicin
- Asparaginase
- Gemtuzumab
- Calicheamicins
Other Study ID Numbers
- IRB00111627
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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