SPIRIT 3 - a phase 3 randomised trial to evaluate the most effective way to use drug treatments in newly diagnosed early stage chronic myeloid leukaemia (cancer of blood which starts in bone marrow) patients

Phase 1

• Conditions: Chronic phase Chronic Myeloid Leukaemia; MedDRA version: 16.0 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005696-14-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

1. Male or female patients = 18 years of age. 2. Patients must fulfill all of the following: i) be diagnosed with chronic phase CML confirmed by blood morphology and RT-PCR for BCR-ABL. ii) be enrolled within 3 months of initial diagnosis of chronic phase CML (date of RT-PCR confirming presence of BCR-ABL) iii) be in confirmed chronic phase ie: a) < 15% blasts in blood (manual differential) b) < 30% blasts plus promyelocytes in blood c) < 20 % basophils in blood d) = 100 x 109 /L platelets e) no evidence of extramedullary leukaemic involvement, with the exception of hepatosplenomegaly 3.Written voluntary informed consent.
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Any prior treatment for CML with any TKI (eg imatinib, dasatinib, nilotinib, bosutinib, ponatinib); busulphan, IFN-alpha, homoharringtonine, cytosine arabinoside, any other investigational agents. 2. Patients who have received prior CML chemotherapy including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (collection of unmobilised PBPCs is allowed at diagnosis). 3. Patients who have had any form of prior haematopoietic stem cell transplant (autograft or allograft). 4. Patients with an ECOG Performance Status Score = 3 5. Patients with serum bilirubin, SGOT/AST, SGPT/ALT or creatinine concentrations > 2.0 x upper limit of normal (ULN) 6. Patients with serum amylase or lipase > 1.5 x ULN, history of acute pancreatitis within 1 year of study, history of chronic pancreatitis, or uncontrolled hypertriglyceridaemia (triglycerides > 450 mg/dL) 7. Patients with significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to a) myocardial infarction, unstable angina and/or congestive heart failure within 6 months prior to study; and b) history of clinically significant atrial arrhythmia; or any ventricular arrhythmia. 8. Patients taking medications known to be associated with Torsade de Pointes (eg amiodarone, azithromycin, chloroquine, citalopram, domperidone, erythromycin, quinidine, sotalol, thioridazine) 9. Patients with known uncontrolled hypertension; systolic blood pressure > 140mm Hg and/or diastolic blood pressure > 90mm Hg 10. Patients with a known INR or PTT > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants, or patients with a known bleeding disorder. Baseline testing of INR is not required. 11. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders or infection. 12. Patients who have undergone major surgery within 4 weeks of starting trial IMP. 13. Patients who are: a) pregnant b) breast feeding c) of childbearing potential without a negative pregnancy test prior to starting trial IMP and d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential). 14. Patients with a history of another malignancy either currently or within the past five years (with the exception of basal cell skin carcinoma in situ). 15. Patients with a history of non-compliance to medical regimens or patients who can envisage being unable to complete the study for any reason. 16. Patients unwilling to receive trial drug via a home delivery method.

Study & Design

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