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Ponatinib with Chemotherapy for Young Adults with Ph+ ALL
NCT02776605Phase 2
Key facts
- Status
- Unknown
- Start
- Jun 2016
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- Fundación PETHEMA
- Modality
- Small Molecules
- Drugs
- ponatinib
- Conditions
- Acute lymphoblastic leukemia, Philadelphia chromosome positive
01
Overview
Phase 2, open-label, single-arm trial of ponatinib in Acute lymphoblastic leukemia, Philadelphia chromosome positive, sponsored by Fundación PETHEMA. Primary endpoints: Overall Response (CHR, CCyR, MMR, CMR) at 2 years and Event Free Survival at 2 years. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Ponatinib + Chemotherapy
Ponatinib combined with standard chemotherapy (PETHEMA ALL Ph08 protocol) followed by HSCT
03
Who it enrols
Young adults (18-55, up to 60) with newly diagnosed Ph+ ALL, adequate organ function, and no significant cardiovascular disease.
04
Endpoints
Primary
Overall Response (CHR, CCyR, MMR, CMR)
Event Free Survival
Secondary
Rate of Allogeneic Hematopoietic Stem Cell Transplant
Frequency of MMR and CMR at time of alloHSCT
Transplant-Related Mortality
Duration of Complete Response
Overall Survival
BCR-ABL Kinase Domain Mutations
Adverse Events and Serious Adverse Events
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