A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400 mg daily versus imatinib 800 mg daily versus imatinib plus PEG interferon-alpha 2a (Pegasys) in patients with newly-diagnosed chronic phasechronic myeloid leukaemia
- Conditions
- Chronic Myeloid LeukaemiaCancer
- Registration Number
- ISRCTN59346371
- Lead Sponsor
- ewcastle upon Tyne Hospitals Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2466
1. Male or female patients 18years or older
2. Patients must have all of the following:
a. Be enrolled within three months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
b. Be previously untreated for CML with the exception of hydroxyurea and/or anagrelide
c. Cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations, patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome
d. Less than 15% blasts in peripheral blood and bone marrow
e. Less than 30% blasts plus promyelocytes in peripheral blood and bone marrow
f. Less than 20% basophils in peripheral blood
g. More than or equal to 100 x 10^9 l platelets
h. No evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly
3. Written voluntary informed consent
1. Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study
2. 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 exceptions
3. 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 diagnosis
4. Patients who have had any form of prior haemopoietic stem cell transplant, eitherautograft or allograft
5. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score more than or equal to three
6. 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 oralanticoagulants
8. 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 Criteria
9. Patients with a prior history of significant psychiatric illness, particularly depression
10. Patients with known positivity for Human Immunodeficiency Virus (HIV); baseline testing for HIV is not required
11. Patients who have undergone major surgery within four weeks of Study Day one, or who have not recovered from prior major surgery
12. Patients who are:
a. Pregnant
b. Breast feeding
c. Of childbearing potential without a negative pregnancy test prior to Study Day one
d. 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 situ
14. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare overall survival in the three arms at five years
- Secondary Outcome Measures
Name Time Method <br> 1. To compare molecular response at one year<br> 2. Treatment tolerability after 5 years<br> 3. health economics after 5 years<br> 4. Quality of life after 5 years<br>