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Myeloid Leukemia, Chronic, Chronic PhasePhase 3SPIRIT2NCT01460693

Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

A Phase 3 study testing Imatinib and Dasatinib in people with Myeloid Leukemia, Chronic, Chronic Phase, run by Newcastle University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probability of progression-free survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Leukemia, Chronic, Chronic Phase
What is being tested?
Imatinib and Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
814 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2008to 7 Mar 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients 18 years or over.
  • Patients must have all of the following:
  • be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
  • cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
  • patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
  • < 15% blasts in peripheral blood and bone marrow;
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  • < 30% blasts plus promyelocytes in peripheral blood and bone marrow;
  • < 20% basophils in peripheral blood,
  • 100 x 109/L platelets or greater
  • no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
  • Written voluntary informed consent.

Who cannot join

  • Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
  • Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). NB patients will be ineligible for the study if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions.
  • Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.)
  • Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
  • Patients with an ECOG Performance Status Score of 2 or less.
  • Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations > 2.0 x the institutional upper limit of the normal range (IULN).
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  • Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
  • Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
  • Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
  • Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
  • Patients who are:
  • pregnant,
  • breast feeding,
  • of childbearing potential without a negative pregnancy test prior to Study Day 1, and
  • 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).
  • 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.
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

About this study

Official title: A Phase III, Prospective Randomised Comparison of Imatinib (STI571, Glivec/Gleevec) 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probability of progression-free survival. Imatinib is not tolerated or effective in some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2 study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of event free survival and therefore will be an effective first-line therapy for newly-diagnosed CML patients. This study will also provide crucial long-term survival, quality of life and health economic data to assist health care providers and managers to determine the most cost-effective drug therapy for CML.

Being tested
Imatinib, Dasatinib
Keywords
Leukemia, Myeloid, Chronic, Chronic-Phase, CML
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImatinibDrug

    Also called Gleevec/Gleevic

    Oral Imatinib 100mg daily

  • DasatinibDrug

    Also called Sprycel

    Oral Dasatinib 100mg daily

Study groups in NCT01460693
Study groupRoleWhat they receive
Arm A - ImatinibActive comparatorImatinib 400mg daily
Receives: Drug: Imatinib
Arm B - DasatinibExperimentalDasatinib 100mg daily
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year event free survival

    To compare 5-year event free survival between the 2 treatment arms. The study aim is to show superiority of the dasatinib arm over the imatinib 400mg arm.

    Measured: ongoing throughout study (5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2011 (estimated)
  2. Study startAug 2008
  3. Primary completion7 Mar 2018
  4. Study completion7 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
814 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460693
Sponsor's protocol ID
4443
Other IDs
2007-006185-15, ISRCTN54923521
Acronym
SPIRIT2
Status last verified
Apr 2018
First submitted
1 Oct 2010
Last updated
24 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Neelakantan P, Gerrard G, Lucas C, Milojkovic D, May P, Wang L, Paliompeis C, Bua M, Reid A, Rezvani K, O'Brien S, Clark R, Goldman J, Marin D. Combining BCR-ABL1 transcript levels at 3 and 6 months in chronic myeloid leukemia: implications for early intervention strategies. Blood. 2013 Apr 4;121(14):2739-42. doi: 10.1182/blood-2012-11-466037. Epub 2013 Feb 4.

    PubMed 23380743

  • Marin D, Hedgley C, Clark RE, Apperley J, Foroni L, Milojkovic D, Pocock C, Goldman JM, O'Brien S. Predictive value of early molecular response in patients with chronic myeloid leukemia treated with first-line dasatinib. Blood. 2012 Jul 12;120(2):291-4. doi: 10.1182/blood-2012-01-407486. Epub 2012 May 29.

    PubMed 22645182

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imatinib and Dasatinib in people with Myeloid Leukemia, Chronic, Chronic Phase, run by Newcastle University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year event free survival (time frame: ongoing throughout study (5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01460693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.

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