European Leukemia Trial Registry
Trial: DASFREE

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Title Evaluating Dasatinib therapy discontinuation in patients with CP-CML with stable CMR
Scientific Title Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
Short Title DASFREE
Trialgroup NN
Type of Trial single-group, open-label
Disease Chronic myeloid leukemia(CML) Chronic Phase
Age >= 18 years
Status No longer recruiting
Start of Recruitment 01.09.2014
Shortprotocol Shortprotocol
Remark Primary Outcome Measures: MMR rate at 12 months [ Time Frame: At 12 months after Dasatinib discontinuation ] [ Designated as safety issue: No ] Major Molecular Response (MMR) rate at 12 months is the proportion of subjects who maintain MMR at 12 months after Dasatinib discontinuation without re-starting Dasatinib treatment in the enrolled subjects in the study Secondary Outcome Measures: Event-free survival (EFS) after Dasatinib discontinuation [ Time Frame: At 12 months after Dasatinib discontinuation ] EFS is defined as survival with no molecular relapse, including no loss of MMR Relapse-free survival (RFS) after Dasatinib discontinuation [ Time Frame: At 6, 18, 24 months and every 6 months thereafter up to 5 years ] [ Designated as safety issue: No ] Relapse is defined as any of the following events while a subject is on study: the loss of MMR, Complete Cytogenetic Response (CCyR), Complete Hematologic Response (CHR) or progression to advanced/blastic phase. RFS is defined as the time from Dasatinib treatment discontinuation to the date of relapse Assessment of BCR-ABL kinetics for subjects who experience loss of Complete Molecular Response (CMR) but not MMR [ Time Frame: Monthly in the first year and every 3 months thereafter up to 5 years ] Assessment of BCR-ABL kinetics in subjects in CMR or less with measurable levels [ Time Frame: Monthly in the first year and every 3 months thereafter up to 5 years ] Rate of transformation to AP/BC [ Time Frame: Up to 5 years or death date ] [ Designated as safety issue: No ] Accelerated Phase (AP) is defined as Blasts in Peripheral Blood (PB) or Bone Marrow (BM) 15-29%; Blast+promyelocytes >=30% with blasts < 30% or Additional Chromosomal Abnormalities (ACA) in Ph+ cells (clonal progression), or basophils in blood >= 20% or platelets <100 x 10(9)/L unrelated to therapy Blastic Phase or Crisis (BP/BC) is defined as Blasts in PB or BM >=30%, or extramedullary blast cell involvement (with the exception of spleen and liver) Progression Free Survival (PFS) [ Time Frame: Up to 5 years or death date ] [ Designated as safety issue: No ] Progression-free survival (PFS) is defined as overall survival plus the additional events progression to accelerated phase or blast crisis Rate of transformation to OS [ Time Frame: Up to 5 years or death date ] [ Designated as safety issue: No ] Overall survival (OS) is defined as the time between first dose date and death date
created 24.09.2014 Hanna Ebert
changed 14.11.2016 Eva-Maria Ableidinger
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