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S TI571 P rospective I nternational R andom I sed T rial

S TI571 P rospective I nternational R andom I sed T rial

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S TI571 P rospective I nternational R andom I sed T rial

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  1. STI571 Prospective International RandomIsed Trial A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus imatinib 800mg daily versus imatinib plus PEGinterferon-alpha 2a (Pegasys) in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia. SPIRIT CML Trial Overview

  2. Contents • Key Facts • Study Summary • Patient recruitment • Inclusion criteria • Consent Forms • Randomisation • Study Schedule • AE’s and SAE’s • PCR analysis • Treatment arm details • Further Information • Website • Forms • eCRF system training SPIRIT CML Trial Overview

  3. Key Facts • NCRN Adopted study • UK Multicentre study • Versions running also in GE and FR - may combine data • Looking for 2466 patients from UK • Current situation • First patient recruited June 2005 • 96 sites now with ethics approval • 248 patients randomised • Electronic Data Capture via internet • Website: www.spirit-cml.org SPIRIT CML Trial Overview

  4. Study Summary • Randomised, Open label • Newly Diagnosed CML (within 3 months) • 2 treatment arms (822 patients on each) • Arm A: 400mg daily imatinib • Arm B: 800mg daily imatinib • Arm C: closed 21 Feb 2008 • Arm C: 400mg daily imatinib plus up to 180mg weekly PEGinterferon a • Primary end point is survival at 5 years • Secondary endpoints include haematologic and cytogenetic responses SPIRIT CML Trial Overview

  5. Patient recruitment • Inclusion criteria • Consent Forms • Randomisation • Study Schedule SPIRIT CML Trial Overview

  6. Eligibility - Inclusion Criteria • ≥ 18 years old. • ALL of the following should apply to patient: i. within 3 months of initial diagnosis of CML-Chronic Phase, ii. Received no CML treatment (but hydroxyurea and/or anagrelide OK), iii. Patient is Philadelphia chromosome positive, iv. Patient has a) < 15% blasts in peripheral blood and bone marrow; b) < 30% blasts plus promyelocytes in peripheral blood and bone marrow; c) < 20% basophils in peripheral blood; d) ≥ 100 x 109/L platelets; e) no extramedullary involvement (except hepatosplenomegaly). • Written voluntary informed consent. SPIRIT CML Trial Overview

  7. Eligibility - Exclusion Criteria (1) • Patient is Ph-negative, BCR-ABL-positive. • Prior treatment for CML. • Prior chemotherapy (any type). • Prior haemopoietic stem cell transplant, either autograft or allograft. • ECOG Score ≥ 3. • Serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine > 2.0 x IULN. • INR or PTT > 1.5 x IULN. • Uncontrolled medical disease. • Prior history of significant psychiatric illness, particularly depression. SPIRIT CML Trial Overview

  8. Eligibility - Exclusion Criteria (2) • HIV-positive (HIV test not required). • Major surgery within 4 weeks of Study Day 1, or not recovered from prior major surgery. • Patient is: a. pregnant, b. breast feeding, c. without a negative pregnancy test, d. unwilling to use barrier contraceptive . • Another malignancy within the past five years. • History of non-compliance to medical regimens or potentially unreliable. SPIRIT CML Trial Overview

  9. Informed Consent • There are 3 consent forms • Participation in the SPIRIT Trial • Donation of material to CML Biobank • CML Patient Registry • The patient only needs to agree to part (1) to be included in the trial. • Remember: Patient Information Sheet and Informed Consent Forms should be printed on Hospital Headed Paper. SPIRIT CML Trial Overview

  10. Randomisation • Fax to Trial Manager (0)191 376 0748. • Signed informed consent form(s) • Cytogenetics report • Create new patient in eCRF • Complete screening eCRF pages • Open visit – visit date • Eligibility criteria • Demography • Randomisation (save as complete) • Randomisation – Patient Set-up • Treatment arm allocation and subject number will then be displayed on screen. SPIRIT CML Trial Overview

  11. Study Schedule (1) Year 1 • Visit 1 – Screening • Visit 2 – Day 28 (1 month) • Visit 3 – Day 56 (2 months) • Visit 4 – Day 84 (3 months) • Visit 5 – 6 months • Visit 6 – 9 months • Visit 7 – 12 months Years 2 – 5 • Visits 8 – 15 • Visits every 6 months SPIRIT CML Trial Overview

  12. Study Schedule (2) • Visit Date – all visits • Eligibility • Demography (NHS number) • Medical History • CML Diagnosis Date • PCR sample – every 3 months • Bone marrow assessment – once a year • Physical examination • Extramedullary Involvement Liver & Spleen • ECOG Score • Quality of Life Questionnaire • Labs (Haem/Biochem) • Adverse Events • Study medication • Concomitant medications Screening only All visits SPIRIT CML Trial Overview

  13. AE’s and SAE’s • Protocol Section 9.3 - discusses Safety Reporting: • An adverse event is defined as any undesirable sign, symptom, or medical condition occurring after starting study drug, whether considered study drug-related or not. • Please ensure that all adverse events (whether related to study drug or not) are recorded in the patient’s electronic case report form (via the SPIRIT website). • A serious adverse event is defined as an event that is: 1. fatal, or life-threatening 2. requires or prolongs hospitalization 3. significantly or permanently disabling 4. is a congenital anomaly 5. any other significant medical event • SAE’s must be faxed to Trial Manager within 24 hours • Fax SPIRIT SAE form to (0)191 376 0748. SPIRIT CML Trial Overview

  14. PCR Samples • PCR analysis - BCR-ABL (secondary endpoint). • Hammersmith Hospital • 20 mls peripheral blood - every 3 months. • First PCR sample (visit 1) - PRIOR to imatinib treatment. • Please label samples and package clearly as 'SPIRIT Trial’ and include Shipping Form. • The samples should be sent via first class post on a Monday, Tuesday or Wednesday only (to avoid samples arriving at the weekend and degrading). SPIRIT CML Trial Overview

  15. Treatment Arms Imatinib • First 400mg daily imatinib in both treatment arms is supplied from usual NHS stock (as per non-trial patient) • A SPIRIT Trial label must be applied • Drug accountability still required – considered IMP • 400mg daily imatinib • No additional supplies required • 800mg daily imatinib • Total daily dose made up from 2 sources: • 400mg daily supplied from NHS stock • 400mg daily supplied from SPIRIT Trial stock • Is usually taken as 400mg BD • Imatinib trial stock supplied to hospital pharmacy directly from Novartis. • If patient is randomisation to 800mg arm, trial manager will automatically order a re-supply of trial stock for pharmacy. SPIRIT CML Trial Overview

  16. Where to get information • Trial manager - Corinne Hedgley • 01280 814 916 • c.a.hedgley@ncl.ac.uk • Website - www.spirit-cml.org • Pharmacy section (information for pharmacists, trial prescription, dispensing logs etc) • Study File section (details study file contents, site logs etc) • Document Centre (protocol, ethical approval and otherdocuments) • Contact details (Trial Manager, Chief Investigator) • Newsletter (study updates) SPIRIT CML Trial Overview

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