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

ewcastle upon Tyne Hospitals Trust (UK)0 sites2,466 target enrollmentMay 18, 2001

ConditionsChronic Myeloid Leukaemia Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Myeloid Leukaemia
Sponsor: ewcastle upon Tyne Hospitals Trust (UK)
Enrollment: 2466
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 18, 2001

End Date

January 1, 2015

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ewcastle upon Tyne Hospitals Trust (UK)

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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