EVALUATION OF SAFETY OF STANDARD CHEMOTHERAPY IN COMBINATION WITH DASATINIB IN ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL)
- Conditions
- Philadelphia chromosome positive Acute Lymphoblastic LeukemiaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022854-18-DE
- Lead Sponsor
- Dekan des Fachbereichs Medizin der Goethe Universität, represented by the Coordinating Investigator
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Confirmed new diagnosis of Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
2.Male or female patients aged 18-55 years
3.Not previously treated except for prephase therapy
4.Signed written inform consent
5.Molecular detection of BCR-ABL transcripts
6.Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least 6 months thereafter
7.Negative pregnancy test for women of child-bearing potential (All women of childbearing potential MUST have a negative pregnancy test within 72 hours prior to receiving the first dose)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients with ECOG status > 2
2. Patients with QTcF > 470 ms
3. Cardiac insufficiency NYHA grade III/IV, LEVF < 50%, myocardial infarction within the past 6 months prior to study
4. Active secondary malignancy requiring treatment
5. Patients with active, uncontrolled bacterial, viral or fungal infection
6. Known infection with HIV, Hepatitis B (except post vaccination profile) or C
7. Inadequate hepatic function defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal and total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia
8. Concurrent severe diseases which exclude the administration of therapy
9. Expected non-compliance or inability to understand informed consent
10. Female patients who are breast feeding,
11. Treatment with other investigational antileukemic agents after informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the feasibility of a combination of Dasatinib and standard chemotherapy in adult ALL;Secondary Objective: - Determine the hematologic response<br>- assess the molecular CR rate during combined Dasatinib and chemotherapy<br>- Assess the frequency and type of bcr-abl tyrosine kinase domain mutations<br>- Determine rate of death during induction and death in complete remission<br>;Primary end point(s): Survival and rate of treatment-related discontinuation of study treatment during induction and consolidation chemotherapy;Timepoint(s) of evaluation of this end point: After consolidation (after approx. 3 Month of treatment)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Molecular CR rate<br>Hematologic CR-rate at end of induction II<br>BCR-ABL mutations occurring during treatment<br>Grade III and IV toxicity by CTC;Timepoint(s) of evaluation of this end point: After consolidation (after approx. 3 Month of treatment)