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Protocol Summary


Protocol No.
PSCI-18-006
Prinicipal Investigator
Naik, Seema
Phase
N/A
Age Group
Adult
Scope
Local
Secondary Protocol No.
18-006
Title
bcr-abl PCR response to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia in Stable Chronic Phase.
Objective
Primary Objective: Establish bcr-abl response to TKI therapy for chronic phase CML with stable molecular response.

Secondary Objectives: Observe molecular responses including complete molecular response of CML CP to TKI therapy with the agents such as imatinib, dasatinib, nilotinib and bosutinib

Primary endpoints: To evaluate log improvement in BCR-ABL blood quantitation after 1 year of combined TKI therapy.

Secondary endpoints:
? Evaluate Safety and Adverse Events.
? Evaluate compliance ? Proportion of Doses taken as per protocol,

Dose Limiting Toxicities.
? Evaluate Major Molecular Response (MMR) and Complete Molecular Remission (CMR) rate based on bcr-abl pcr for monitoring of CML at 3 monthly intervals while on TKI treatment for CML in chronic phase.
Applicable Disease Sites
Other
Status
Open
Participating Institutions
Hershey Medical Center