Chronic Myeloid LeukemiaPhase 2NordCML006NCT00852566
Randomized Study Comparing the Effect of Dasatinib and Imatinib on Malignant Stem Cells in Chronic Myeloid Leukemia
A Phase 2 study testing Imatinib and Dasatinib in people with Chronic Myeloid Leukemia, run by Norwegian University of Science and Technology at 7 sites in 3 countries.
Trial summary
A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia… 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 and Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Mar 2009to Dec 2015
- 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
- Patients are able to provide written informed consent
- Patients must have CML in CP which is defined by the presence of all of the following criteria:
- < 15% blasts in peripheral blood (PB) and BM.
- < 30% blasts plus promyelocytes in PB and BM.
- < 20% basophils in the PB.
- ≥ 100 x 109/L platelets.
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- No evidence of extramedullary leukemia apart from hepatosplenomegaly
- Ph+ or variants must be demonstrated by BM cytogenetics, FISH or PCR.
- Previously untreated CML in CP, with the exception of hydroxyurea or anagrelide
- Patients must be enrolled in this study within 90 days after the date of first being diagnosed with CML
- ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
- Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT≤ 2.5 times the institutional ULN.
- Adequate renal function defined as serum creatinine ≤ 2 times the institutional ULN.
- Men and women, ages 18 years and older.
- Adequate BM aspiration sample before the start of study treatment (i.e sample is sufficient for stem cell analysis)
- Potentially fertile women must use an adequate method of contraception to avoid pregnancy throughout the study.
- Potentially fertile women must have a negative serum or urine pregnancy test
Who cannot join
- Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- Women who are pregnant or breastfeeding.
- Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Known pleural effusion at baseline.
- Uncontrolled or significant cardiovascular disease
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- History of significant bleeding disorder unrelated to CML, including:
- Prior chemotherapy for peripheral stem cell mobilization.
- Inadequate BM aspiration sample due to marrow fibrosis or other reasons
- Prior or concurrent malignancy
- Severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent
- Abuse of alcohol, prescribed or illicit drugs
- Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.
- Prohibited Treatments and/or Therapies
- Any prior treatment with interferon
- Any prior treatment with dasatinib
- Any prior treatment with imatinib
- Any other prior systemic treatments, with anti-CML activity [except for anagrelide, or hydroxyurea (HU)].
- Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes as described in Appendix 3.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Norway3 sites
Bergen University Central Hospital
Bergen
Rikshospitalet
Oslo, 0027
St. Olavs Hospital
Trondheim, 7006
Sweden3 sites
Lund University Hospital
Lund, 22185
Karolinska University Hospital
Stockholm, 17176
Uppsala University Hospital
Uppsala, 75185
About this study
Official title: An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells With Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid
A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18 months and approximately 40 patients will be recruited to the study.
Read the detailed description
An Open-Label, Randomized, Multicenter Phase II Trial Comparing the depletion of malignant stem cells with Dasatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Estimated Number of Study Centers and Countries/Regions: Appr. 12 sites in 5 Nordic countries. Stem cell analyses will be performed in 4 Nordic centers (Helsinki, Lund, Oslo and Stockholm).
Study Phase: II
Research Hypothesis: Treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) patients.
Primary Objective: To compare the number of Ph-positive cells in the stem cell compartment in newly diagnosed CP CML patients treated with dasatinib 100 mg QD vs. imatinib 400 mg QD.
Study Design: open-label randomized Phase II trial in newly diagnosed CML patients in CP. Patients will be randomized to receive dasatinib at a starting dose of 100 mg QD or imatinib at a starting dose of 400 mg QD.
Duration of Study: The study will be open for enrollment until the planned number of 40 patients is randomized. All patients will be treated and/or followed for up to 18 months. Based on the amendment 1 (Oct 2011), the follow-up of the patients will continue additional 4 years until 31.12.2015.
Number of Patients per Group: Approximately 40 patients will be randomized, 20 patients to dasatinib and 20 to imatinib. Additional patients will be recruited in case insufficient amount of representative samples have been obtained from first 40 patients.
Study Population: Patients 18 years or older with a newly diagnosed CP CML, not previously treated with any systemic treatments for CML
Study Assessments and Endpoints:
All stem cell assays are based on the preselection of CD34+ cells from large volume of bone marrow (BM) aspirates using paramagnetic beads. The CD34+ fraction will be further subdivided based on the expression of CD38 marker (positive vs. negative) using a sorting flow cytometer.
The primary endpoint is a comparison of proportion of Ph-positive cells in stem cell compartments (CD34+CD38neg and CD34+CD38+) at 6 months between the study arms.
Secondary endpoints are comparisons between treatment arms for: (1) the number of Ph-positive cells in all stem cell compartments at 1 and 3 months, (2) BCR-ABL RQ-PCR in blood at 1, 3, 6, 12 and 18 months, and (3) rate of CCyR within 3, 6, 12 and 18 months.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Imatinib, Dasatinib
- Keywords
- Chronic myeloid leukemia, tyrosine kinase inhibitor, stem cell, Philadelphia chromosome, dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Glivec
Per oral imatinib 400mg once daily (continuous medication)
DasatinibDrug
Also called Sprycel
Per oral dasatinib 100mg once daily (continuous medication)
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Active comparator | Standard treatment Imatinib 400mg OD Receives: Drug: Imatinib |
| dasatinib | Experimental | Dasatinib 100mg OD Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph-positive cells in stem cell compartments
proportion of Ph-positive cells in stem cell compartments (CD34+CD38neg and CD34+CD38+)
Measured: 6 months
Secondary outcomes (1)
BCR-ABL RQ-PCR in blood
Measured: up to 18 months (1, 3, 6, 12 and 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satu Mustjoki, MD, PhD, Principal investigator, Helsinki University Central Hospital, helsinki, FinlandHenrik Hjorth-Hansen, MD, PhD, Study chair, St. Olavs HospitalOle Weiss-Bjerrum, MD, PhD, Study chair, Copenhagen University Hospital, RigshospitaletIngunn Dybedal, MD, PhD, Study chair, Rikshospitalet, Oslo, NorwayTobias Gedde-Dahl, MD, PhD, Study chair, Rikshospitalet, Oslo, NorwayKimmo Porkka, MD, PhD, Study chair, Helsinki University Central Hospital, Helsinki, FinlandJohan Richter, MD, PhD, Study chair, University of Lund, Lund, SwedenBengt Simonsson, MD, PhD, Study chair, University Hospital, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852566
- Sponsor's protocol ID
- 2008-004106-13
- Other IDs
- 2008
- Acronym
- NordCML006
- Status last verified
- Sep 2017
- First submitted
- 26 Feb 2009
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hjorth-Hansen H, Stenke L, Soderlund S, Dreimane A, Ehrencrona H, Gedde-Dahl T, Gjertsen BT, Hoglund M, Koskenvesa P, Lotfi K, Majeed W, Markevarn B, Ohm L, Olsson-Stromberg U, Remes K, Suominen M, Simonsson B, Porkka K, Mustjoki S, Richter J; Nordic CML Study Group. Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006). Eur J Haematol. 2015 Mar;94(3):243-50. doi: 10.1111/ejh.12423. Epub 2014 Sep 13.
PubMed 25082346Christiansson L, Soderlund S, Mangsbo S, Hjorth-Hansen H, Hoglund M, Markevarn B, Richter J, Stenke L, Mustjoki S, Loskog A, Olsson-Stromberg U. The tyrosine kinase inhibitors imatinib and dasatinib reduce myeloid suppressor cells and release effector lymphocyte responses. Mol Cancer Ther. 2015 May;14(5):1181-91. doi: 10.1158/1535-7163.MCT-14-0849. Epub 2015 Mar 11.
PubMed 25761894Mustjoki S, Richter J, Barbany G, Ehrencrona H, Fioretos T, Gedde-Dahl T, Gjertsen BT, Hovland R, Hernesniemi S, Josefsen D, Koskenvesa P, Dybedal I, Markevarn B, Olofsson T, Olsson-Stromberg U, Rapakko K, Thunberg S, Stenke L, Simonsson B, Porkka K, Hjorth-Hansen H; Nordic CML Study Group (NCMLSG). Impact of malignant stem cell burden on therapy outcome in newly diagnosed chronic myeloid leukemia patients. Leukemia. 2013 Jul;27(7):1520-6. doi: 10.1038/leu.2013.19. Epub 2013 Jan 18.
PubMed 23328954
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells With Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid
- ClinicalTrials.gov ID
- NCT00852566
- Acronym / sponsor ID
- NordCML006 / 2008-004106-13
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia, tyrosine kinase inhibitor, stem cell, Philadelphia chromosome, dasatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18 months and approximately 40 patients will be recruited to the study.
Detailed description
An Open-Label, Randomized, Multicenter Phase II Trial Comparing the depletion of malignant stem cells with Dasatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Estimated Number of Study Centers and Countries/Regions: Appr. 12 sites in 5 Nordic countries. Stem cell analyses will be performed in 4 Nordic centers (Helsinki, Lund, Oslo and Stockholm).
Study Phase: II
Research Hypothesis: Treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) patients.
Primary Objective: To compare the number of Ph-positive cells in the stem cell compartment in newly diagnosed CP CML patients treated with dasatinib 100 mg QD vs. imatinib 400 mg QD.
Study Design: open-label randomized Phase II trial in newly diagnosed CML patients in CP. Patients will be randomized to receive dasatinib at a starting dose of 100 mg QD or imatinib at a starting dose of 400 mg QD.
Duration of Study: The study will be open for enrollment until the planned number of 40 patients is randomized. All patients will be treated and/or followed for up to 18 months. Based on the amendment 1 (Oct 2011), the follow-up of the patients will continue additional 4 years until 31.12.2015.
Number of Patients per Group: Approximately 40 patients will be randomized, 20 patients to dasatinib and 20 to imatinib. Additional patients will be recruited in case insufficient amount of representative samples have been obtained from first 40 patients.
Study Population: Patients 18 years or older with a newly diagnosed CP CML, not previously treated with any systemic treatments for CML
Study Assessments and Endpoints:
All stem cell assays are based on the preselection of CD34+ cells from large volume of bone marrow (BM) aspirates using paramagnetic beads. The CD34+ fraction will be further subdivided based on the expression of CD38 marker (positive vs. negative) using a sorting flow cytometer.
The primary endpoint is a comparison of proportion of Ph-positive cells in stem cell compartments (CD34+CD38neg and CD34+CD38+) at 6 months between the study arms.
Secondary endpoints are comparisons between treatment arms for: (1) the number of Ph-positive cells in all stem cell compartments at 1 and 3 months, (2) BCR-ABL RQ-PCR in blood at 1, 3, 6, 12 and 18 months, and (3) rate of CCyR within 3, 6, 12 and 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib | Active comparator | Drug: ImatinibStandard treatment Imatinib 400mg OD |
| dasatinib | Experimental | Drug: DasatinibDasatinib 100mg OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients are able to provide written informed consent
- Patients must have CML in CP which is defined by the presence of all of the following criteria:
- Patients must be enrolled in this study within 90 days after the date of first being diagnosed with CML
- ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
- Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT≤ 2.5 times the institutional ULN.
Key exclusion criteria (19 listed)
- Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- Women who are pregnant or breastfeeding.
- Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Known pleural effusion at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: GlivecPer oral imatinib 400mg once daily (continuous medication) | Drug | Imatinib |
| DasatinibAlso: SprycelPer oral dasatinib 100mg once daily (continuous medication) | Drug | dasatinib |
Primary outcome
Ph-positive cells in stem cell compartments
Time frame: 6 months
proportion of Ph-positive cells in stem cell compartments (CD34+CD38neg and CD34+CD38+)
1 secondary outcome
BCR-ABL RQ-PCR in blood
Time frame: up to 18 months (1, 3, 6, 12 and 18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publication: PubMed 25082346Hjorth-Hansen H, Stenke L, Soderlund S, Dreimane A, Ehrencrona H, Gedde-Dahl T, Gjertsen BT, Hoglund M, Koskenvesa P, Lotfi K, Majeed W, Markevarn B, Ohm L, Olsson-Stromberg U, Remes K, Suominen M, Simonsson B, Porkka K, Mustjoki S, Richter J; Nordic CML Study Group. Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006). Eur J Haematol. 2015 Mar;94(3):243-50. doi: 10.1111/ejh.12423. Epub 2014 Sep 13.
- Derived from this study: PubMed 25761894Christiansson L, Soderlund S, Mangsbo S, Hjorth-Hansen H, Hoglund M, Markevarn B, Richter J, Stenke L, Mustjoki S, Loskog A, Olsson-Stromberg U. The tyrosine kinase inhibitors imatinib and dasatinib reduce myeloid suppressor cells and release effector lymphocyte responses. Mol Cancer Ther. 2015 May;14(5):1181-91. doi: 10.1158/1535-7163.MCT-14-0849. Epub 2015 Mar 11.
- Derived from this study: PubMed 23328954Mustjoki S, Richter J, Barbany G, Ehrencrona H, Fioretos T, Gedde-Dahl T, Gjertsen BT, Hovland R, Hernesniemi S, Josefsen D, Koskenvesa P, Dybedal I, Markevarn B, Olofsson T, Olsson-Stromberg U, Rapakko K, Thunberg S, Stenke L, Simonsson B, Porkka K, Hjorth-Hansen H; Nordic CML Study Group (NCMLSG). Impact of malignant stem cell burden on therapy outcome in newly diagnosed chronic myeloid leukemia patients. Leukemia. 2013 Jul;27(7):1520-6. doi: 10.1038/leu.2013.19. Epub 2013 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satu Mustjoki, MD, PhD principal investigator
Helsinki University Central Hospital, helsinki, Finland
Henrik Hjorth-Hansen, MD, PhD study chair
St. Olavs Hospital
Ole Weiss-Bjerrum, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib and Dasatinib in people with Chronic Myeloid Leukemia, run by Norwegian University of Science and Technology at 7 sites in 3 countries.
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 17 inclusion and 19 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway, Sweden, Finland. 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?
Ph-positive cells in stem cell compartments (time frame: 6 months). 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 NCT00852566, which also lists 3 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 25 Sep 2017.