Expanded Access Program of Ponatinib
NCT01592136 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2018-02-06
Summary
This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.
Conditions
- Chronic Myeloid Leukemia (CML)
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Interventions
- DRUG
-
ponatinib
Patients will receive ponatinib 45 mg orally as a single dose once daily with or without food. Each patient will receive daily ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent
Sponsors & Collaborators
-
Ariad Pharmaceuticals
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
Phase II Front-line Ponatinib in Adult Philadelphia+/BCR-ABL+ Acute Lymphoblastic Leukemia.
NCT01641107 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04501614 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid Leukemia
NCT04709731 ·Status: UNKNOWN ·Phase: PHASE2
-
The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation
NCT04233346 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL
NCT04722848 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
NCT02467270 ·Status: COMPLETED ·Phase: PHASE2
-
Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse
NCT04475731 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib
NCT01746836 ·Status: RECRUITING ·Phase: PHASE2
-
Study in Adult Ph-positive ALL
NCT04688983 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Chronic Myeloid Leukemia
NCT04043676 ·Status: UNKNOWN ·Phase: PHASE2
-
Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients
NCT05306301 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph+ ALL
NCT04554459 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
NCT04070443 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia
NCT02627677 ·Status: TERMINATED ·Phase: PHASE3
-
Retrospective Evaluation of CML Patients in the National Compassionate Program
NCT02448095 ·Status: TERMINATED
-
Nilotinib, for Patients With CML-CP or CML-AP
NCT04518644 ·Status: NO_LONGER_AVAILABLE
-
Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia
NCT03263572 ·Status: RECRUITING ·Phase: PHASE2
-
Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL
NCT07301424 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
NCT01657682 ·Status: COMPLETED ·Phase: PHASE2
-
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
NCT03250338 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
NCT01522469 ·Status: COMPLETED ·Phase: PHASE2
-
Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04845035 ·Status: WITHDRAWN ·Phase: PHASE2
-
Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
NCT03933852 ·Status: UNKNOWN
-
Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib
NCT02398825 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
NCT03934372 ·Status: RECRUITING ·Phase: PHASE1/PHASE2