Treatment with two drugs, Dasatinib and Blinatumomab, for the patients with a form of cancer which affects the cells which give origin to white cells (cells present in blood) who have not been treated previously with other drugs for this pathology.

Phase 1

• Conditions: Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive (Ph+); MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001083-11-IT
• Lead Sponsor: FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1) Newly diagnosed adult B-precursor Ph+ ALL patients.
2) Age greater or equal to18 years.
3) Signed written informed consent according to ICH/EU/GCP and national local laws.
4) ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.
5) Renal and hepatic function as defined below:
o AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN) o Total bilirubin <1.5 x ULN
o Creatinine clearance equal or greater than 50 mL/min
6) Pancreatic function as defined below:
o Serum amylase less or equal to 1.5 x ULN
o Serum lipase less or equal to1.5 x ULN
7) Normal cardiac function.
8) Negative HIV test, negative HBV DNA and HCV RNA.
9) Negative pregnancy test in women of childbearing potential.
10) Bone marrow specimen from primary diagnosis available.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Prior systemic chemotherapy for leukemia and/or CD19-directed therapy
2) History of or current relevant CNS pathology (current =grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).
3) Impaired cardiac function, including any one of the following:
-LVEF (Left Ventricular Ejection Fraction) <45% as determined by MUGA (multigated acquisition) scan or echocardiogram.
-Complete left bundle branch block.
-Use of a cardiac pacemaker.
-ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
-Congenital long QT syndrome.
-History of or presence of significant ventricular or atrial arrhythmia.
-Clinically significant resting bradycardia (<50 beats per minute).
-QTc >450 msec on screening ECG (using the QTcF formula).
-Right bundle branch block plus left anterior hemiblock, bifascicular block.
-Myocardial infarction within 3 months prior to starting Dasatinib.
-Angina pectoris.
4) Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
5) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
6) History of or current autoimmune disease.
7) Systemic cancer chemotherapy within 2 weeks prior to study.
8) Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
9) Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
10) Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
11) Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter, or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified