Chronic phase CML patients with BCR-ABL/ABLIS transcript levels below MR3 (0.0032%) at the time of accrual. MedDRA version: 20.0 Level: LLT Classification code 10009015 Term: Chronic myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: SPRYCEL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DASATINIB
CAS Number: 302962-49-8
Current Sponsor code: n.a.
Other descriptive name: DASATINIB
Concentration unit: mg m
Sponsors
AIL CATANIA ASSOCIAZIONE ITALIANA CONTRO LEUCEMIE-LINFOMI E MIELOMA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic phase CML patients with BCR-ABL/ABLIS transcript levels below MR3 (0.0032%) at the time of accrual. BCR-ABL/ABLIS transcripts will be validated in the Laboratory of Experimental Oncology and Hematology directed by the Coordinator Center. MR3 must be confirmed by 2 consecutive RT-Q-PCR with MR3. 2. Female or male >18 years of age at the time of accrual. 3. Patients currently receiving IM 400 mg/qd as the first line of treatment for no less than 3 months. Prior exposure to Hydroxyurea is permitted. 4. Female patients of childbearing potential, and male patients, must agree to use an effective barrier method of birth control, as appropriate, throughout the study and for up to 24 months following TKI discontinuation. 5. Written informed consent will be signed prior to any study procedures being performed. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 111 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 111
Exclusion criteria
Exclusion criteria: 1. Prior treatment with a TKI other than IM or Interferon. 2. Known severe hypersensitivity to DAS treatment or any of the excipients of this product. 3. Previous history of Pulmonary Arterial Hypertension or Pleural Effusions. 4. Any medical condition that might be aggravated by treatment or that can not be controlled: i.e. active infection, unstable diabetes mellitus or all serious concomitant disorders incompatible with the study including active autoimmune disorders. 5. Concurrent treatment with any other experimental or anti-cancer therapy. 6. Patients with a history of other malignancies, except if there is a disease-free interval of at least 5 years. 7. Women who are pregnant or breast feeding, or of childbearing potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test at the enrollment. Post-menopausal women must have amenorrhoea for at least 12 months to be considered of non-childbearing potential. 8. Patients with overt cognitive dysfunctions hampering a self-reported QoL evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rates of MR4.5 by 12 months of treatment.;Secondary Objective: • Rates of confirmed MR4.5 at 12 months of treatment; • Rates of undetectable BCR-ABL1 transcripts; • Rates of confirmed undetectable BCR-ABL1 transcripts; • Rates of treatment discontinuation; • Duration of treatment discontinuation without disease relapse; • Rates of disease relapse after treatment discontinuation; • Rates of disease response to TKI treatment after relapse occurring following drug discontinuation; • Overall Survival; • Progression-Free Survival; • Event-Free Survival; • Failure-Free Survival; • Quality of Life (using EORTC forms: QLQ-C30 and QLQ-CML).;Primary end point(s): Rates of MR4.5 by 12 months of treatment.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of confirmed undetectable BCR-ABL1 transcripts.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactRegulatory Manager
Clinical Trial Consulting ss di Aquilani e Scala
Outcome results
None listed