Study: NCT02829840

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ponatinib
Description: Part 1: Ponatinib at starting dose of 30 mg by mouth every day for one 28 day cycle.~Part 2 Phase I Dose Escalation: Ponatinib at starting dose of 30 mg by mouth every day of a 28 day cycle.~Part 2 Phase II Dose Expansion: Ponatinib at maximum tolerated dose from Phase I by mouth every day of a 28 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ponatinib
Description: Part 1: Ponatinib at starting dose of 30 mg by mouth every day for one 28 day cycle.~Part 2 Phase I Dose Escalation: Ponatinib at starting dose of 30 mg by mouth every day of a 28 day cycle.~Part 2 Phase II Dose Expansion: Ponatinib at maximum tolerated dose from Phase I by mouth every day of a 28 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ponatinib
Description: Part 1: Ponatinib at starting dose of 30 mg by mouth every day for one 28 day cycle.~Part 2 Phase I Dose Escalation: Ponatinib at starting dose of 30 mg by mouth every day of a 28 day cycle.~Part 2 Phase II Dose Expansion: Ponatinib at maximum tolerated dose from Phase I by mouth every day of a 28 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-azacytidine
Description: Part 2 Phase I Dose Escalation: 5-azacytidine at dose of 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) for on Days 1-7 of every 28 day cycle.~Part 2 Phase II Dose Expansion: 5-azacytidine 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) on Days 1-7 of every 28 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-azacytidine
Description: Part 2 Phase I Dose Escalation: 5-azacytidine at dose of 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) for on Days 1-7 of every 28 day cycle.~Part 2 Phase II Dose Expansion: 5-azacytidine 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) on Days 1-7 of every 28 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-azacytidine
Description: Part 2 Phase I Dose Escalation: 5-azacytidine at dose of 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) for on Days 1-7 of every 28 day cycle.~Part 2 Phase II Dose Expansion: 5-azacytidine 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) on Days 1-7 of every 28 day cycle.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Phone Calls
Description: About 30 days after end-of-study visit, study staff calls participant and asks if they have had any side effects and/or started any new treatment(s).~If disease appears to be responding to study drugs, study staff calls participant every 3-6 months for up to 5 years and asks how they are doing and about any side effects they may be having.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Phone Calls
Description: About 30 days after end-of-study visit, study staff calls participant and asks if they have had any side effects and/or started any new treatment(s).~If disease appears to be responding to study drugs, study staff calls participant every 3-6 months for up to 5 years and asks how they are doing and about any side effects they may be having.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Phone Calls
Description: About 30 days after end-of-study visit, study staff calls participant and asks if they have had any side effects and/or started any new treatment(s).~If disease appears to be responding to study drugs, study staff calls participant every 3-6 months for up to 5 years and asks how they are doing and about any side effects they may be having.