Clinical Trial: Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official 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 Mole
Brief Summary: The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.
Detailed Summary: Primary Purpose: Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs
Sponsor: Bristol-Myers Squibb
Current Primary Outcome: MMR rate at 12 months [ Time Frame: At 12 months after Dasatinib discontinuation ]
Original Primary Outcome:
- MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Monthly once up to first year ]Major Molecular Response (MMR) is defined as BCR-ABL transcripts <0.1% on International Scale, at 12 month after Dasatinib discontinuation in patients who have maintained MMR without re-starting Dasatinib
- MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Every 3 months in years 2 to 5 ]
Current Secondary Outcome:
- 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 6,12,18, 24 months and every 6 months thereafter up to 5 years ]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 ]
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 ]Progression-free survival (PFS) is defined as overall survival plus the additional events progression to accelerated phase or blast crisis
- Overall survival (OS) [ Time Frame: Up to 5 years or death date ]Overall survival (OS) is defined as the time between first dose date and death date
Original Secondary Outcome:
- 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 ]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 or has a serious drug toxicity. 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 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 and OS [ Time Frame: Up to 5 years or death date ]
Accelerated Phase (AP) is defined as Blasts in Peripheral Blood (PB) or Bone Marrow (BM) 15-29%; Blast+promyelocytes ≥50% or ACA in Ph+ cells (clonal progression), or platelets <100 x 109/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)
Overall survival (OS) is defined as the time between first dose date and death date
Information By: Bristol-Myers Squibb
Dates:
Date Received: May 8, 2013
Date Started: October 2013
Date Completion: November 2021
Last Updated: April 17, 2017
Last Verified: November 2016