Name | Type | Description | Interventions |
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AZA+ADE | AZA+FLAG+Ida | AE | MA | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- G-CSF
- Dexrazoxane
|
DAC+ADE | DAC+FLAG+Ida | AE | MA | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- G-CSF
- Dexrazoxane
|
AZA+ADE | AZA+FLAG+Ida+Sor | AZA+AE+Sor | AZA+MA+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Sorafenib
- G-CSF
- Dexrazoxane
|
DAC+ADE | DAC+FLAG+Ida+Sor | DAC+AE+Sor|DAC+MA+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Sorafenib
- G-CSF
- Dexrazoxane
|
AZA+ADE | AZA+FLAG+Ida | AE | MA | Asp+AraC | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- G-CSF
- Dexrazoxane
|
DAC+ADE | DAC+FLAG+Ida | AE | MA | Asp+AraC | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- G-CSF
- Dexrazoxane
|
AZA| +ADE | +FLAG+Ida+Sor| +AE+Sor| +MA+Sor| +Asp+AraC+Sor | Experimental | 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, ITMHA. | - Azacitidine
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
DAC|+ADE | +FLAG+Ida+Sor | +AE+Sor | +MA+Sor | +Asp+AraC+Sor | Experimental | 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, ITMHA. | - Decitabine
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
AZA+ADE | AZA+FLAG-Ida+Sor | AE | MA+Sor | Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
DAC+ADE | DAC+FLAG+Ida+Sor | AE | MA+Sor | Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
AZA | + ADE | +FLAG+Ida+Sor| +AE+Sor | +MA+Sor | +Asp+AraC+Sor | Experimental | 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, ITMHA. | - Azacitidine
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
DAC |+ADE |+FLAG+Ida+Sor |+AE+Sor|+MA+Sor|+Asp+AraC+Sor | Experimental | 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, ITMHA. | - Decitabine
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
|
AZA+ADE | AZA+FLAG+Ida+Sor | MA+Sor | Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
- Stem Cell Transplant
|
DAC+ADE | DAC+FLAG+Ida+Sor | MA+Sor | Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
- Stem Cell Transplant
|
DAC |+ADE|+FLAG+Ida+Sor|+MA+Sor|+Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
- Stem Cell Transplant
|
AZA |+ADE|+FLAG+Ida+Sor|+MA+Sor|+Asp+AraC+Sor | Experimental | 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
- Cytarabine
- Daunorubicin
- Etoposide
- Idarubicin
- Fludarabine
- Mitoxantrone
- Erwinia asparaginase
- Sorafenib
- G-CSF
- Dexrazoxane
- Stem Cell Transplant
|