First line treatment for a kind of cancer which affects the generating cells of the white cells with a potent drug preventing the uncontrolled proliferation of the cancer cells. Study in elderly patients and in patients unfit for intensive antitumor drugs and for replacement of the cells from which result from blood cells.

• Conditions: Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL); MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002761-35-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-16
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. To be classified as having Ph+ ALL, patients must have >20% blasts in bone marrow at the time of diagnosis and no prior history of CML. 2. Patients with previously untreated Ph+ and/or BCR/ABL + ALL: - age = 60 years old or - age = 18 years old, but unfit for program of intensive therapy and allogeneic SCT 3. Signed written informed const according to ICH/EU/GCP and national local laws. 4. Effective contraception.
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Uncontrolled congestive heart failure or/and uncontrolled hypertension. 2. History of myocardial infarction within 3 months, or uncontrolled angina pectoris. 3. Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula) . 4. WHO performance status = 50% (Karnofsky) or = 3 (ECOG). 5. Active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN. 6. Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day. 7. History of acute pancreatitis within 1 year of study, or history of chronic pancreatitis, history of alcohol abuse; ongoing or active infection; uncontrolled hypertriglyceridemia (triglicerides > 450 mg/dL). 8. Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., severe malabsorption syndrome, or extended small bowel resection). 9. Patients who are currently receiving treatment with any of the medications listed in Appendix D if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix D have the potential to prolong QT. 10. Patients who have received any investigational drug = 4 weeks. 11. Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 12. Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Ponatinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs. 13. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 14. Patients unwilling or unable to comply with the protocol.

Study & Design

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