Chronic Phase of Chronic Myeloid LeukemiaPhase 2NCT01872442
Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase
A Phase 2 study testing Dasatinib and Peg-Interferon alpha2b in people with Chronic Phase of Chronic Myeloid Leukemia, run by Poitiers University Hospital.
Trial summary
Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Phase of Chronic Myeloid Leukemia
- What is being tested?
- Dasatinib and Peg-Interferon alpha2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 15 Oct 2013to 31 Oct 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent.
- Target Population
- a)18 to 65 years b)Newly diagnosed (≤ 3 months) Philadelphia chromosome positive chronic CP-CML c)Major BCR-ABL transcripts d)Not previously treated for CML except with hydroxyurea or anagrelide e)ECOG Performance Status≤ 2 f)Adequate Organ Function. i)Total bilirubin< 2.0 times the institutional Upper Limit of Normal ii)Hepatic enzymes(AST, ALT )≤ 2.5 ULN iii)Serum Na, K+, Mg2+ and Ca2+ > Lower Limit of Normal (LLN) or supplemented iv)Serum Creatinine< 1.5 ULN g)Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
- Free subject, without guardianship nor subordination,
- Health insurance coverage. -
Who cannot join
- Patients with BCR-ABL other than M-BCR-ABL, Philadelphia negative CML.
- Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).
- Medical history and concurrent diseases :
- Hypersensitivity to any of the excipients of dasatinib
- Prior treatment with Interferon-α, contraindication to interferon-α, hypersensitivity to any of the excipients of PegIFNα2b,
- Concomitant immunosuppressive treatment or corticosteroids,
Show all 20Show fewer
- Preexisting thyroid disease unless it is controlled with conventional treatment, Auto-immune thyroiditis,
- Autoimmune disorder, Chronic liver disease,
- Prior or ongoing severe psychiatric disease,
- Epilepsy or compromised central nervous system(CNS) function,
- HIV positivity, chronic hepatitis B or C,
- Uncontrolled or significant cardio vascular or pulmonary disease,
- i)Uncontrolled angina, myocardial infarction or congestive heart failure within 6 months, ii)Echocardiography with LVF < 45% or LLN, peak velocity of tricuspid regurgitant flow > 2,8 m/s iii)Pulmonary arterial hypertension (PAH), iv)Any history of clinically significant ventricular or supraventricular arrhythmias, v)Diagnosed congenital long QT syndrome, vi)Prolonged QTc interval > 450 msec (Fredericia) on 3 pre-entry electrocardiogram, vii)Subjects with hypokalemia or hypomagnesemia if it cannot be corrected, j)Other malignant disease during the last 5 years prior to the inclusion except basal cell carcinoma of the skin or carcinoma in situ of the cervix, k)History of significant bleeding disorder unrelated to CML, including: i)Diagnosed congenital bleeding disorders (e.g. von Willebrand's disease), ii)Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding. l)Another severe or life -threatening medical disease.
- Women who are pregnant or breastfeeding, WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug.
- Prohibited treatments and/or therapies:
- strong inhibitors of the CYP3A4,
- category I drugs that are generally accepted to have a risk of causing "Torsades de Pointes", Patients must discontinue the drug minimum 7 days prior to starting dasatinib.
- History /any condition for poor compliance to the treatment.
- Inability to freely provide consent through judiciary or administrative condition.
- Ongoing participation to another study.
About this study
Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators address the question of the efficacy and safety of dasatinib in combination with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia in Chronic phase.
- Being tested
- Dasatinib, Peg-Interferon alpha2b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Dasatinib 100mg daily starting at inclusion
If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes > 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study
Peg-Interferon alpha2bDrug
30 µg weekly starting month 4- month 21
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib,Bristol Myers Squibb Receives: Drug: Dasatinib; Drug: Peg-Interferon alpha2b |
| Peg-Interferon alpha2b | Experimental | Peg-Interferon alpha2b (Peg-IFN α2b), Merck Receives: Drug: Dasatinib; Drug: Peg-Interferon alpha2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of molecular response
Molecular response 4.5 (MR4.5) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.0032 on the international scale or by undetectable BCR-ABL with the analysis of at least 32000 copies of ABL (according to the ELN recommendations by N. Cross et al., leukemia 2012).
Centralized analyses of molecular response by RTQPCR will be performed for all molecular assessments in this study.
Measured: at 12 months.
Secondary outcomes (5)
Rate of complete cytogenetic response
Measured: 3, 6, 12, 18, 24 months, and every 12 months thereafter.
Rate of major molecular responses
Measured: 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Rate of molecular response
Rate of molecular response 4.5 and 5.0
Measured: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Kinetics and duration
Cumulative rate, Kinetics and duration CCR, MMR, MR4.5, MR5.0
Measured: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter
Rate of PegIFN-α2b and dasatinib discontinuation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start15 Oct 2013
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Phase of Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lydia ROY, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872442
- Sponsor's protocol ID
- DASA-PegIFN
- Status last verified
- Feb 2020
- First submitted
- 14 May 2013
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roy L, Chomel JC, Guilhot J, Guerci-Bresler A, Escoffre-Barbe M, Giraudier S, Charbonnier A, Dubruille V, Huguet F, Johnson-Ansah H, Lenain P, Ame S, Etienne G, Nicolini FE, Rea D, Cony-Makhoul P, Courby S, Ianotto JC, Legros L, Machet A, Coiteux V, Hermet E, Cayssials E, Bouchet S, Mahon FX, Rousselot P, Guilhot F; French CML Group (FiLMC). Dasatinib plus Peg-Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA-PegIFN study). Br J Haematol. 2023 Jan;200(2):175-186. doi: 10.1111/bjh.18486. Epub 2022 Oct 10.
PubMed 36214090
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase
- ClinicalTrials.gov ID
- NCT01872442
- Acronym / sponsor ID
- DASA-PegIFN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Jun 2013 (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.
Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators address the question of the efficacy and safety of dasatinib in combination with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia in Chronic phase.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: Dasatinib, Drug: Peg-Interferon alpha2bDasatinib,Bristol Myers Squibb |
| Peg-Interferon alpha2b | Experimental | Drug: Dasatinib, Drug: Peg-Interferon alpha2bPeg-Interferon alpha2b (Peg-IFN α2b), Merck |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Written Informed Consent.
- Target Population
- a)18 to 65 years b)Newly diagnosed (≤ 3 months) Philadelphia chromosome positive chronic CP-CML c)Major BCR-ABL transcripts d)Not previously treated for CML except with hydroxyurea or anagrelide e)ECOG Performance Status≤ 2 f)Adequate Organ Function. i)Total bilirubin< 2.0 times the institutional Upper Limit of Normal ii)Hepatic enzymes(AST, ALT )≤ 2.5 ULN iii)Serum Na, K+, Mg2+ and Ca2+ > Lower Limit of Normal (LLN) or supplemented iv)Serum Creatinine< 1.5 ULN g)Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
- Free subject, without guardianship nor subordination,
- Health insurance coverage. -
Key exclusion criteria (20 listed)
- Patients with BCR-ABL other than M-BCR-ABL, Philadelphia negative CML.
- Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).
- Medical history and concurrent diseases :
- i)Uncontrolled angina, myocardial infarction or congestive heart failure within 6 months, ii)Echocardiography with LVF < 45% or LLN, peak velocity of tricuspid regurgitant flow > 2,8 m/s iii)Pulmonary arterial hypertension (PAH), iv)Any history of clinically significant ventricular or supraventricular arrhythmias, v)Diagnosed congenital long QT syndrome, vi)Prolonged QTc interval > 450 msec (Fredericia) on 3 pre-entry electrocardiogram, vii)Subjects with hypokalemia or hypomagnesemia if it cannot be corrected, j)Other malignant disease during the last 5 years prior to the inclusion except basal cell carcinoma of the skin or carcinoma in situ of the cervix, k)History of significant bleeding disorder unrelated to CML, including: i)Diagnosed congenital bleeding disorders (e.g. von Willebrand's disease), ii)Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding. l)Another severe or life -threatening medical disease.
- Women who are pregnant or breastfeeding, WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug.
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 |
|---|---|---|
| DasatinibDasatinib 100mg daily starting at inclusion If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes > 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study | Drug | Dasatinib, Peg-Interferon alpha2b |
| Peg-Interferon alpha2b30 µg weekly starting month 4- month 21 | Drug | Dasatinib, Peg-Interferon alpha2b |
Primary outcome
Cumulative rate of molecular response
Time frame: at 12 months.
Molecular response 4.5 (MR4.5) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.0032 on the international scale or by undetectable BCR-ABL with the analysis of at least 32000 copies of ABL (according to the ELN recommendations by N. Cross et al., leukemia 2012). Centralized analyses of molecular response by RTQPCR will be performed for all molecular assessments in this study.
5 secondary outcomes
Rate of complete cytogenetic response
Time frame: 3, 6, 12, 18, 24 months, and every 12 months thereafter.
Rate of major molecular responses
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Rate of molecular response
Time frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
Kinetics and duration
Time frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter
Rate of PegIFN-α2b and dasatinib discontinuation
Time frame: 24 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 10 Feb 2020.
- Derived from this study: PubMed 36214090Roy L, Chomel JC, Guilhot J, Guerci-Bresler A, Escoffre-Barbe M, Giraudier S, Charbonnier A, Dubruille V, Huguet F, Johnson-Ansah H, Lenain P, Ame S, Etienne G, Nicolini FE, Rea D, Cony-Makhoul P, Courby S, Ianotto JC, Legros L, Machet A, Coiteux V, Hermet E, Cayssials E, Bouchet S, Mahon FX, Rousselot P, Guilhot F; French CML Group (FiLMC). Dasatinib plus Peg-Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA-PegIFN study). Br J Haematol. 2023 Jan;200(2):175-186. doi: 10.1111/bjh.18486. Epub 2022 Oct 10.
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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.
Lydia ROY, MD principal investigator
Poitiers University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and Peg-Interferon alpha2b in people with Chronic Phase of Chronic Myeloid Leukemia, run by Poitiers University Hospital.
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 5 inclusion and 20 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Cumulative rate of molecular response (time frame: at 12 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 NCT01872442, 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 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.