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 (ALL05)
Australasian Leukaemia and Lymphoma Group (ALLG)Dataset description
Dataset includes: Data for 20 patients Patients with Philadelphia positive ALL Introduced testing of desatinib (TKI) Includes Diagnostic information about patients (demographic and diagnostic details, Treatment, clinical outcome, serial info on BCR/ABL testing Full patient cohort achieved Complete and clean datasetSubjects
Chemotherapy |Identifiers
Source Study
Trial name (public)
Dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic LeukaemiaTrial acronym
ALL5
Trial ID
ACTRN12607000609459
Purpose
Treatment
Phase
Phase 2
Funding
Commercial sector/Industry,Bristol-Myers Squibb Australia
Scientific enquiries
A/Prof Associate Professor Andrew Grigg
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 .... Read more
Key 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
Key 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)
Can healthy volunteers participate?
No
Population
Sample Size 20
Min. age 16 Years
Max. age 70 Years
Sex Both males and females
Condition category Philadelphia Chromosone-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL)
Condition code Cancer
Intervention
Intervention code Treatment: Drugs
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.
Comparison
Control group Uncontrolled
No comparator/control
Outcomes
Outcome: Haematological toxicity. Measured as the incidence of prolonged myelosuppression.Timepoint: Interim analysis after completion of dasatinib plus chemotherapy in first 8 patients; final analysis after 20 patients.
Outcome: The incidence of grade 3-4 non-haematological toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events) attributable to dasatinib.Timepoint: Interim analysis after completion of dasatinib plus chemotherapy in first 8 patients; final analysis after 20 patients.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis Assessed on a case-by-case basis