A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT03164057
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
206 participants
INTERVENTIONAL
2017-06-15
2027-06-30
Brief Summary
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PRIMARY OBJECTIVES:
* Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks.
* Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients.
SECONDARY OBJECTIVES
* Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi.
* Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.
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Detailed Description
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Treatment will consist of 5 blocks of conventional chemotherapy: Induction I, Induction II, Intensification I, Intensification II, and Intensification III over approximately 5 months.
RANDOMIZATION: Patients will be randomized to receive one of two DMTi (azacitidine or decitabine) for 5 days prior to Induction I. Intrathecal (ITHMA) treatments will be given right before treatment on this study or on Day 1 of Induction I treatment. Leucovorin will be given 24-30 hours following ITHMA.
INDUCTION I CHEMOTHERAPY: Patients receive cytarabine, daunorubicin, and etoposide.
INDUCTION II CHEMOTHERAPY; Patients receive their assigned DMTi for 5 days followed by fludarabine, cytarabine, G-CSF, and idarubicin.
Patients are then evaluated and assigned to either the low-risk arm, intermediate-risk arm, or the high-risk arm for Intensification therapy.
Patients with ≥ 5% blasts following Induction II will be considered refractory and will go off therapy. The rare high risk patient with an MRD \< 0.1% following Induction I may proceed directly to stem cell transplant (SCT) after Induction II - if a suitable donor is available and the transplant can be performed without delay. MDS patients may proceed to SCT once they have achieved MRD \<0.1% irrespective of the number of chemotherapy courses received.
INTENSIFICATION I CHEMOTHERAPY - LOW-RISK AML, INTERMEDIATE-RISK AML, and HIGH-RISK AML with no donor: Patients receive cytarabine and etoposide. After administration of 5 days of a DMTi prior to Inductions I and II satisfies a tolerability determination criterion, patients will also receive their randomly assigned DMTi for five days prior to cytarabine and etoposide.
INTENSIFICATION II CHEMOTHERAPY - LOW RISK AML, INTERMEDIATE-RISK AML, and HIGH-RISK AML with no donor: Patients receive mitoxantrone and cytarabine. After administration of 5 days of a DMTi prior to Inductions I and II satisfies a tolerability determination criterion, patients will also receive their randomly assigned DMTi for five days prior to mitoxantrone and cytarabine.
INTENSIFICATION I CHEMOTHERAPY - HIGH-RISK AML with a donor: Patients receive mitoxantrone and cytarabine followed by stem cell transplant (SCT). Treatment related AML patients and patients with treatment related MDS who have a donor but are not able to receive a SCT without delay will proceed to HR Intensification III and receive erwinia asparaginase and cytarabine. After administration of 5 days of a DMTi prior to earlier courses satisfies a tolerability criterion, patients will also receive their randomly assigned DMTi for five days prior to mitoxantrone and cytarabine or erwinia asparaginase and cytarabine.
Treatment related AML patients and treatment related MDS patients that are not able to receive a SCT should go off treatment following Intensification II.
INTENSIFICATION III CHEMOTHERAPY - INTERMEDIATE-RISK AML and HIGH-RISK AML with no donor: Patients receive erwinia asparaginase and cytarabine. After administration of 5 days of a DMTi prior to earlier courses satisfies a tolerability criterion, patients will also receive their randomly assigned DMTi for five days prior to erwinia asparaginase and cytarabine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AZA+ADE | AZA+FLAG+Ida | AE | MA
Part 1 Tolerability with AZA - Low Risk
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and then receive low-risk intensifications I \& II without azacitidine.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide,dexrazoxane, fludarabine, idarubicin, G-CSF, mitoxantrone., ITMHA.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
DAC+ADE | DAC+FLAG+Ida | AE | MA
Part 1 Tolerability with DAC - Low Risk
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and then receive low-risk Intensifications I \& II without decitabine.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
AZA+ADE | AZA+FLAG+Ida+Sor | AZA+AE+Sor | AZA+MA+Sor
Part 2 Dose Expansion with AZA - Low Risk
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and low- risk Intensifications I \& II. Sorafenib will be given to patients with FLT3-ITD. For these patients, AZA will be limited to the first two courses of Induction chemotherapy. They will not receive AZA with Intensification therapy.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, ITMHA.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
DAC+ADE | DAC+FLAG+Ida+Sor | DAC+AE+Sor|DAC+MA+Sor
Part 2 Dose Expansion with DAC - Low Risk
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and low-risk Intensifications I \& II. Sorafenib will be given to patients with FLT3-ITD. For these patients, DAC will be limited to the first two courses of Induction chemotherapy. They will not receive DAC with Intensification therapy.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
AZA+ADE | AZA+FLAG+Ida | AE | MA | Asp+AraC
Part 1 Tolerability with AZA - Intermediate Risk
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and then receive intermediate risk Intensifications I, II \& III without azacitidine.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA,
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
DAC+ADE | DAC+FLAG+Ida | AE | MA | Asp+AraC
Part 1 Tolerability with DAC - Intermediate Risk
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and then receive intermediate-risk Intensifications I, II \& III without decitabine.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
AZA| +ADE | +FLAG+Ida+Sor| +AE+Sor| +MA+Sor| +Asp+AraC+Sor
Part 2 Dose Expansion with AZA - Intermediate-Risk
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and intermediate-risk Intensification I, II, and III. Sorafenib will be given to patients with FLT3-ITD. For these patients, AZA will be limited to the first two courses of Induction chemotherapy. They will not receive AZA with Intensification therapy.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, asparaginase erwinia chrysanthemi (recombinant)-rywn, ITMHA.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
DAC|+ADE | +FLAG+Ida+Sor | +AE+Sor | +MA+Sor | +Asp+AraC+Sor
Part 2 Dose Expansion with DAC - Intermediate-Risk
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and intermediate-risk Intensifications I, II and III. Sorafenib will be given to patients with FLT3-ITD. For these patients, DAC will be limited to the first two courses of Induction chemotherapy. They will not receive DAC with Intensification therapy.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, asparaginase erwinia chrysanthemi (recombinant)-rywn, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
AZA+ADE | AZA+FLAG-Ida+Sor | AE | MA+Sor | Asp+AraC+Sor
Part 1 Tolerability with AZA - High Risk (no donor)
Patients are randomized to receive 5 days of single agent azacitidine as part of Induction I \& II and high-risk intensifications I, II \& III without azacitidine. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
DAC+ADE | DAC+FLAG+Ida+Sor | AE | MA+Sor | Asp+AraC+Sor
Part 1 Tolerability with DAC - High Risk (no donor)
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and then receive high-risk Intensifications I, II \& III without decitabine. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
AZA | + ADE | +FLAG+Ida+Sor| +AE+Sor | +MA+Sor | +Asp+AraC+Sor
Part 2 Dose Expansion with AZA - High Risk (no donor)
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and high-risk Intensifications I, II and III. Sorafenib will be given to patients with FLT3-ITD. For these patients, AZA will be limited to the first two courses of Induction chemotherapy. They will not receive AZA with Intensification therapy.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, asparaginase erwinia chrysanthemi (recombinant)-rywn, ITMHA.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
DAC |+ADE |+FLAG+Ida+Sor |+AE+Sor|+MA+Sor|+Asp+AraC+Sor
Part 2 Dose Expansion with DAC - High Risk (no donor)
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and high-risk Intensifications I, II and III. Sorafenib will be given to patients with FLT3-ITD. For these patients, DAC will be limited to the first two courses of Induction chemotherapy. They will not receive DAC with Intensification therapy.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, asparaginase erwinia chrysanthemi (recombinant)-rywn, ITMHA.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
AZA+ADE | AZA+FLAG+Ida+Sor | MA+Sor | Asp+AraC+Sor
Part 1 Tolerability with AZA- High Risk (with donor)
Patients are randomized to receive 5 days of single agent azacitidine as part of Induction I Induction II and high-risk Intensifications I or high risk intensification III without azacitidine. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations.
Interventions: azacitidine cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
DAC+ADE | DAC+FLAG+Ida+Sor | MA+Sor | Asp+AraC+Sor
Part 1 Tolerability with DAC - High Risk (with donor)
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and then receive high-risk Intensifications I or high risk intensification III without decitabine. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
DAC |+ADE|+FLAG+Ida+Sor|+MA+Sor|+Asp+AraC+Sor
Part 2 Dose Expansion with DAC - High Risk (with donor)
Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I \& II and high-risk Intensifications I or high risk intensification III. Patients will proceed to stem cell transplant. Sorafenib will be given to patients with FLT3-ITD. For these patients, DAC will be limited to the first two courses of Induction chemotherapy. They will not receive DAC with Intensification therapy.
Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
AZA |+ADE|+FLAG+Ida+Sor|+MA+Sor|+Asp+AraC+Sor
Part 2 Dose Expansion with AZA - High Risk (with donor)
Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I \& II and high-risk Intensification I or high risk intensification III. Patients will proceed to stem cell transplant. Sorafenib will be given to patients with FLT3-ITD. For these patients, AZA will be limited to the first two courses of Induction chemotherapy. They will not receive AZA with Intensification therapy.
Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G-CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant.
Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
Interventions
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Azacitidine
Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
Decitabine
Administered intravenously (IV) over approximately one hour.
Cytarabine
Given IV or intrathecally (IT).
Daunorubicin
Given IV.
Etoposide
Given IV.
ITMHA
Given IT.
Idarubicin
Given IV.
Fludarabine
Given IV over approximately 30 minutes.
Mitoxantrone
Given IV.
Erwinia asparaginase
Given IV or intramuscularly (IM).
Sorafenib
Given PO.
G-CSF
Given IV.
Dexrazoxane
Given IV immediately before idarubicin administration.
Stem Cell Transplant
The transplant protocol will depend on the patient's donor and transplant physician's preference.
Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn
May be used in the event of an Erwinia asparaginase shortage. Given intramuscularly (IM).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute myeloid leukemia fulfilling the criteria of the WHO Classification (see Appendix I), or
* \>5% but \< 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality \[e.g., t(8;21), inv(16), t(9;11)\], or
* Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic sarcoma, or chloroma), with or without evidence of a leukemia process in the bone marrow or peripheral blood, with confirmation of myeloid differentiation, or
* High grade myelodysplastic syndrome (MDS) with greater than 5% blasts, or
* Patients with treatment related myeloid neoplasms including AML and MDS, provided their cumulative anthracycline dose has not exceeded 230 mg/m2 doxorubicin equivalents.
* Other criteria - Patients must meet all the following criteria:
* Age \> 28 days and \< 22 years at time of study entry inclusive, and
* No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less for hyperleukocytosis), and
* Written informed consent according to institutional guidelines, and
* Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment, and
* Male and female participants of reproductive potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Exclusion Criteria
* Acute promyelocytic leukemia (APL)
* BCR-ABL1 chronic myeloid leukemia in blast crisis (CML-BC)
* Juvenile myelomonocytic leukemia (JMML)
* Fanconi anemia (FA)
* Kostmann syndrome
* Shwachman syndrome
* Other bone marrow failure syndromes or low grade (\<5% bone marrow blasts) MDS.
* Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
* Use of investigational agents within 30 days or any anticancer therapy for this malignancy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as specified in the protocol document. The patient must have recovered from all acute toxicities from any previous therapy.
* Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Pregnant or lactating.
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
* Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as specified in the protocol document. The patient must have recovered from all acute toxicities from any previous therapy.
* Patients with treatment related myeloid neoplasms with cumulative anthracyclines greater than 230 mg/m2 doxorubicin equivalents.
29 Days
21 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Raul C. Ribiero, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Children's Hospital of Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Rady Children's Hospital and Health Center
San Diego, California, United States
University of Chicago Children's Hospital (Comer)
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2017-00928
Identifier Type: REGISTRY
Identifier Source: secondary_id
AML16
Identifier Type: -
Identifier Source: org_study_id
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