A Phase II study in adult patients with newly-diagnosed chronic myeloid leukaemia of initial intensified Glivec® therapy, and sequential combination therapy for non-responders. With Protocol Amendments October 2004: to include an Extension Phase of the Study

Phase 2

Completed

• Conditions: Chronic myeloid leukaemia (CML); Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12607000614493
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-02-16
• Study Start: 2007-11-29
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1.Male or female patients between 16 and 75 years of age inclusive. Patients must have all of the following:
2.i.be enrolled within 6 months of initial diagnosis of CML-CP
ii.be previously untreated for CML with the exception of hydroxyurea and/or anagrelide,
iii.cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations; OR molecular (PCR) confirmation of bcr-abl gene rearrangement(s);
iv.(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
v.no evidence of extramedullary leukemic involvement, with the exception of the spleen and liver,
3.Written voluntary informed consent.
4.Patients with an Eastern Cooperative Oncology Group performance status score of 2 or less.
5.Patients with serum bilirubin, Serum glutamic oxaloacetic transaminase, Serum glutamic pyruvic transaminase and creatinine concentrations <1.5x the institutional upper limits of normal (ULN).
6.Patients with a coagulation international normalised ratio (INR) and a partial thromboplastin time (PTT) <1.5x the institutional ULN, with the exception of allowing inclusion of patients on oral anticoagulant therapy.

Exclusion Criteria

1.Patients who have received other investigational agents.
2.Patients with secondary chromosomal abnormalities in their CML cells.
3.Patients who received prior chemotherapy. Previous treatment with hydroxyurea is allowed.
4.Patients with uncontrolled medical disease
5.Patients with a positive test for human immunodeficiency virus
6.Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
7.Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (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).
8.Patients with a history of another malignancy within the past five years, with the exception of adequately-treated basal or squamous cell skin carcinoma or cervical carcinoma in situ.
9.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