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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	26 September 2023
Main ID:	ACTRN12607000614493
Date of registration:	29/11/2007
Prospective Registration:	No
Primary sponsor:	Australasian Leukaemia and Lymphoma Group
Public title:	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
Scientific title:	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, in order to assess response and survival
Date of first enrolment:	21/10/2002
Target sample size:	100
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12607000614493.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
Phase:	Phase 2

Countries of recruitment
Australia

Contacts

Name:	A/Prof Timothy Hughes
Address:	Division of Haematology Institute of Medical and Veterinary Science Frome Road Adelaide SA 5000 Australia
Telephone:	+61 8 82223330
Email:	tim.hughes@imvs.sa.gov.au
Affiliation:

Name:	A/Prof Timothy Hughes
Address:	Division of Haematology Institute of Medical and Veterinary Science Frome Road Adelaide SA 5000 Australia
Telephone:	+61 8 82223330
Email:	tim.hughes@imvs.sa.gov.au
Affiliation:

Key inclusion & exclusion criteria

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.

Age minimum: 16 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Leukaemia - Chronic leukaemia

Chronic myeloid leukaemia (CML);
Chronic myeloid leukaemia (CML)

Intervention(s)

1. All patients receive higher dose imatinib – 600 mg/day
2. in eligible patients dose increased to 800 mg based on time dependent response targets
3. In eligible patients cytosine arabinoside added to imatinib if response targets are not reached

Primary Outcome(s)

To assess overall rates and duration of complete cytogenetic response (CCR) and molecular response (MR) achieved using a schedule of intensive, escalated and combination therapy with Glivec, in association with filgrastim support, in adults with newly-diagnosed chronic-phase CML over the 2 year study period.[ Every 3 months for 8 years]

Secondary Outcome(s)

1. To assess overall rates and duration of response, Quality of Life using European Quality of Life 5 Dimension (EQ-5D) Health Questionnaire and overall survival.[ Every 3 months for 8 years]

5. To assess subsequent levels of response to imatinib in patients who show continuing response at 24 months on Study, by Quantitative Polymerase Chain Reaction (Q-PCR) analysis of 3-monthly blood samples for the ratio of BCR-ABL/BCRL transcripts, for up to six further years of an Extension Phase to this Study.[ Every 3 months for 8 years]

6. To evaluate reasons for loss of response to imatinib in patients on the Extension Phase of this Study, if and when Q-PCR analysis of 3-monthly blood samples (for up to six further years) shows a 2-fold increase in bcr-abl transcripts, by mutation analyses of BCR-ABL genes.[ Every 3 months for 8 years]

4. To determine the tolerability, quality of life, and safety of initial therapy with Glivec? 600mg daily, and escalated therapy with Glivec 800mg daily, and subsequent combined sequential therapy with Glivec and Cytosine arabinoside[ Every 3 months for 8 years]

2. To determine the safety and efficacy of filgrastim[ Every 3 months for 2 years]

3. To determine the patterns of change of CML disease load in blood and/or bone marrow over time[ Every 3 months for 8 years]

Secondary ID(s)

Australasian Leukaemia and Lymphoma Group CML6

Source(s) of Monetary Support

Amgen Australia

Novartis Australia

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 09/10/2002
Contact:

Royal Adelaide Hospital

Status: Approved
Approval date: 14/10/2002
Contact:

Royal North Shore Hospital

Status: Approved
Approval date: 21/11/2002
Contact:

Royal Perth Hospital

Status: Approved
Approval date: 22/11/2002
Contact:

Royal Brisbane Hospital

Status: Approved
Approval date: 18/11/2004
Contact:

St Vincent's Hospital Melbourne

Status: Approved
Approval date: 02/03/2005
Contact:

Westmead Hospital