Dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia

Phase 2

Completed

• Conditions: Philadelphia Chromosone-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL); Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12607000609459
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group (ALLG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-28
• Study Completion: 2018-05-14
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients aged between 16 and 70 years (inclusive)
2.Patients with a confirmed diagnosis of Ph+ ALL
3.Female patients of childbearing potential must have a negative pregnancy test, conducted within 7 days prior to registration.
4.Patient has given written informed consent.
5.Previously untreated with antineoplastic therapy for Ph+ A

Exclusion Criteria

1.Exposure to any other investigational agents within 30 days of registration.
2.Known sensitivity to dasatinib
3.Eastern Cooperative Oncology Group (ECOG) performance status score > 2
4.Left ventricular ejection fraction < 50%
5.Creatinine >/= 1.5 x the upper limit of normal (ULN)
6.Serum bilirubin >/= 2 x ULN
7.AST or ALT > 2.5 x ULN
8.Known HIV or hepatitis B seropositivity
9.Pregnancy or breastfeeding
10. Prior diagnosis or evidence of chronic myeloid leukaemia (CML)

Study & Design

• Study Type: Interventional
• Study Design: Not specified