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Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Stephen G
O'Brien
+44 (0)191 282 0605
s.g.o'brien@ncl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Chronic Myeloid Leukaemia
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study2. Any prior treatment for CML with busulphan, interferon-alpha, imatinib, homoharringtonine, cytosine arabinoside, or any other investigational agents (hydroxyurea and anagrelide are the only drugs permitted)N.B. patients will be ineligible for SPIRIT if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions3. Patients who received prior chemotherapy, including regimens used in Peripheral Blood Progenitor Cells (PBPCs) mobilization for haematopoietic progenitor-cell transplantation. It is allowable to collect unmobilized PBPCs at diagnosis4. Patients who have had any form of prior haemopoietic stem cell transplant, eitherautograft or allograft5. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score more than or equal to three6. Patients with serum bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT)/aspartate aminotransferase (AST), Serum Glutamic Pyruvic Transaminase (SGPT)/alanine aminotransferase (ALT), or creatinine concentrations more than 2.0 x the Institutional Upper Limit of the Normal range (IULN)7. Patients with International Normalised Ratio (INR) or Partial Thromboplastin Time (PTT) more than 1.5 x IULN, with the exception of patients on treatment with oralanticoagulants8. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade three/four cardiac problems as defined by the New York Heart Association Criteria9. Patients with a prior history of significant psychiatric illness, particularly depression10. Patients with known positivity for Human Immunodeficiency Virus (HIV); baseline testing for HIV is not required11. Patients who have undergone major surgery within four weeks of Study Day one, or who have not recovered from prior major surgery12. Patients who are:a. Pregnantb. Breast feedingc. Of childbearing potential without a negative pregnancy test prior to Study Day oned. Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)13. Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ14. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Dr
Stephen G
O'Brien
+44 (0)191 282 0605
s.g.o'brien@ncl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Newcastle upon Tyne Hospitals Trust (UK) and funded by Novartis Pharma AG (Switzerland); Roche Pharmaceuticals (Switzerland).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
