Dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia

A Phase II Study of Dasatinib Combined with Induction Chemotherapy in Previously Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia to Assess Safety and Tolerability

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000609459

Acronym

ALL5

Enrollment

Registered

2007-11-28

Start date

2008-11-07

Completion date

2012-04-27

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a study of the drug Dasatinib combined with chemotherapy for treating people with acute lymphoblastic leukaemia (cancer of bone marrow and white blood cells) who also have the Philadelphia Chromosome. Who is it for? You can join this study if you: - are aged 16–70 years - have the Philadelphia Chromosome - have acute lymphoblastic leukaemia which has not yet been treated. Trial details: All participants will receive Dasatinib tablets for 7 days prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Each course of Dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given. Dasatinib is used to reduce the risk of relapse by killing cells with mutations that might otherwise be resistant to the more commonly used drug in this situation, called imatinib. The trial aims to assess the effectiveness, safety and tolerability of Dasatinib plus chemotherapy.

Interventions

Patients will receive a 7 day ‘pre-phase’ of dasatinib (70mg tablets, twice daily) prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Intensive chemotherapy consists of alternating courses of hyper-CVAD (cyclophosphamide, vincristine, Adriamycicn, and dexamethasone) with methotrexate plus cytarabine. Each course of dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Healthy volunteers

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+ ALL

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)

Outcome results