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

Bristol-Myers Squibb28 sites in 6 countries84 target enrollmentJanuary 22, 2014

ConditionsChronic Phase Chronic Myeloid Leukemia

InterventionsDasatinib

DrugsDasatinib

Overview

Phase: Phase 2
Intervention: Dasatinib
Conditions: Chronic Phase Chronic Myeloid Leukemia
Sponsor: Bristol-Myers Squibb
Enrollment: 84
Locations: 28
Primary Endpoint: Major Molecular Response (MMR) Rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 Description

Primary Purpose: Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs

Registry

clinicaltrials.gov

Start Date

January 22, 2014

End Date

October 8, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Target Disease Exceptions
•Patients who have not achieved a 1-log reduction in BCR-ABL transcript levels compared with baseline as determined by local standards or \> 10% IS \[International Standard\]) documented at 3.0-6.5 months since the initial start of dasatinib therapy.
•Patients who have previously undergone hematopoietic stem cell transplantation (SCT) or who are scheduled for SCT
•Previous diagnosis of CML accelerated phase or blast crisis
•Medical History and Concurrent Diseases
•Prior or concurrent malignancy, except the following:
•Curatively treated basal cell or squamous cell skin cancer
•Cervical carcinoma in situ
•Adequately treated Stage I or II cancer from which the subject is currently in complete remission
•Any other cancer from which the subject has been disease free for 3 years

Arms & Interventions

Dasatinib

Dasatinib 50, 80, 100, 140, 180 mg tablets by mouth, once daily, up to 60 months

Intervention: Dasatinib

Outcomes

Primary Outcomes

Major Molecular Response (MMR) Rate

Time Frame: At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)

Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts \< 0.1% on the International Scale \[IS\]) at 12 months after Dasatinib discontinuation without restarting Dasatinib

Secondary Outcomes

Event-Free Survival (EFS) Rate(From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months))
Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC)(From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months))
Overall Survival (OS)(From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months))
Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR)(60 months after last dose)
Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR)(From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months))
Progression Free Survival(From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months))
Relapse-Free Survival (RFS) Rate(From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months))
Progression Free Survival (PFS) Rate(From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months))