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Chronic Myeloid LeukemiaPhase 2CML003NCT00514969

Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase

A Phase 2 study testing Imatinib (STI571) in people with Chronic Myeloid Leukemia, run by University of Bologna at 1 site in Italy.

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

This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Imatinib (STI571)
How many people
Not given
Where
1 siteItaly
Study dates
Aug 2000to not given
Phase
Phase 2
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 of age
  • Accelerated phase of CML defined as the presence of one or more of the following:
  • percentage of blasts in blood or bone marrow * 15% but < 30%
  • percentage of blasts plus promyelocytes in the peripheral blood or bone marrow * 30% (providing that < 30% blasts are present in the bone marrow)
  • peripheral basophils * 20%
  • thrombocytopenia < 100 x 109/L unrelated to therapy These criteria must be met within 4 weeks of administration of first dose of trial treatment.
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  • Blastic phase of CML defined as the presence of one or more of the following:
  • percentage of blasts in blood or bone marrow * 30%
  • percentage of blasts and promyelocytes in blood or bone marrow * 50%
  • documented extramedullary blast involvement (skin, lymph node, bone, lung).
  • Voluntary written informed consent.

Who cannot join

  • Patients of childbearing potential wihout a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions are to be used throughout the trial in both sexes.
  • Patients with an ECOG Performance Status Score ** 3 (see Section 7.2.1)
  • Creatinine levels more than 2 x's the ULN at the laboratory where the analysis was performed.
  • Total serum bilirubin more than 1.5 x's the upper limit of the normal range (ULN) at the laboratory where the analyses were performed; in patients with clinically suspected leukemic involvement of the liver, total bilirubin more than 3 x's the ULN
  • AST (SGOT) or ALT (SGPT) more than 3 x's the upper limit of the normal range (ULN) at the laboratory where the analyses were performed; in patients with clinically suspected leukemic involvement of the liver, AST and ALT more than 5 x's the ULN
  • Patients receiving treatment with interferon-alpha within 48 hours of Day 1.
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  • Patients receiving treatment with hydroxyurea within 24 hours of Day 1
  • Patients receiving treatment with homoharringtonine within 14 days of Day 1
  • Patients receiving treatment with low-dose cytosine arabinoside (< 30 mg/m2 every 12 to 24 hours administered daily) within seven days of Day 1
  • Patients receiving treatment with moderate dose cytosine arabinoside (100-200 mg/m2 for 5 to 6 days) within 14 days of Day 1.
  • Patients receiving treatment with high-dose cytosine arabinoside (1-3 g(m2 every 12 to 24 hours for six to 12 doses) within 28 days of Day 1.
  • Patients receiving anthracyclines, mitoxantrone, etoposide, methotrexate or cyclophosphamide within 21 days of Day1.
  • Patients receiving busulfan within six weeks of Day 1.
  • Patients receiving anti-leukemic agents not included in Exclusion Criteria 6-13 should not begin treatment with STI571 until sufficient time has elapsed for potential recovery to have occurred in the nadir in blood counts. In practice, a full recovery of blood counts may not be possible due to progression of the underlying disease.
  • Patients receiving any hematopoietic stem cell transplantation and who have not achieved full hematopoietic recovery following the transplant
  • Patients receiving any other investigational agents within 28 days of Day 1.
  • Patients with Grade ¾ cardiac disease.
  • Patients with any serious concomitant medical condition
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
  • Patients with a prior diagnosis of accelerated or blastic phase who are in remission and do not fit inclusion criteria, are not eligible.
  • Patients who are likely to be submitted to any procedure of stem cell transplantation before the end of the treatment (6 months), are not eligible.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

    Bologna

Other trials in Italy

About this study

Official title: Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase. A Phase II Study

This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive additional therapy during Part 2 of the trial provided that, in the opinion of the investigator, the patient has benefited from treatment with STI571 and in the absence of safety concerns. During Part 2 (which is of indefinite duration), patients will continue to receive STI571 on a daily basis until either death, the development of intolerable toxicity or the investigator feels it is no longer in the patient's best interest to continue therapy, whichever comes first.

Being tested
Imatinib (STI571)
Keywords
accelerated and blastic phase, STI571
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis

What participants receive

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

  • Imatinib (STI571)Drug

What is being measured

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

  1. To determine the rate of hematological response lasting * 4 weeks in adult patients with Ph chromosome positive CML in accelerated and blastic phase

Secondary outcomes (1)

  1. duration of hematological response and overall survival, cytogenetic response and safety

Timeline

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

  1. First posted10 Aug 2007 (estimated)
  2. Study startAug 2000

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00514969
Sponsor's protocol ID
CML003
Acronym
CML003
Status last verified
Jul 2007
First submitted
9 Aug 2007
Last updated
10 Aug 2007
Results posted
No

Publications

  • Palandri F, Castagnetti F, Testoni N, Luatti S, Marzocchi G, Bassi S, Breccia M, Alimena G, Pungolino E, Rege-Cambrin G, Varaldo R, Miglino M, Specchia G, Zuffa E, Ferrara F, Bocchia M, Saglio G, Pane F, Alberti D, Martinelli G, Baccarani M, Rosti G; GIMEMA Working Party on Chronic Myeloid Leukemia. Chronic myeloid leukemia in blast crisis treated with imatinib 600 mg: outcome of the patients alive after a 6-year follow-up. Haematologica. 2008 Dec;93(12):1792-6. doi: 10.3324/haematol.13068. Epub 2008 Oct 6.

    PubMed 18838477

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib (STI571) in people with Chronic Myeloid Leukemia, run by University of Bologna at 1 site in Italy.

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 21 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 10 Aug 2007. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To determine the rate of hematological response lasting * 4 weeks in adult patients with Ph chromosome positive CML in accelerated and blastic phase. 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 NCT00514969, which also lists 1 linked publication.

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 10 Aug 2007.

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