Chronic Myeloid LeukemiaPhase 2DASAPOSTNCT01802450
Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase
A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia, run by PETHEMA Foundation at 15 sites in Spain.
Trial summary
Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600. 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?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 15 sitesSpain
- Study dates
- Mar 2013to Dec 2016
- 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
- Adult patients >or = 18 years
- Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase
- Treated with Imatinib 400 mg per day or 600 mg per day for at least 18 months. A wash out period of at least 7 days for imatinib is required prior to dasatinib administration
- Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response
- Ability to understand and voluntarily sign the informed consent for
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 72 hours prior to study drug start.
- Sexually active men must also use effective contraceptive methods during the treatment.
- Women must not be breastfeeding
Who cannot join
- Patients treated with Imatinib at a dose different of 400/600 mg per day
- Patients treated with other TKI than imatinib
- Loss of cytogenetic response at study entry
- ECOG ≥ 3
- Inadequate bone marrow reserve: ANC <1.5 x 109/L and/or Platelet count < 100 x 109/L
- Inadequate hepatic function (Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)> 2.5 X institutional upper limit of normal (IULN). Total bilirubin > 1.5 X IULN (unless Gilbert syndrome has been diagnosed)
Show all 14Show fewer
- Inadequate renal function (serum Cr >3 UNL or ClCr <45 ml/min)
- Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy
- Patients with uncontrolled concurrent disease:
- Known pleural effusion at baseline Clinically-significant gastrointestinal disease or surgery that would compromise absorption of study drug (eg, uncontrolled nausea or malabsorption syndrome) Clinically-significant known coagulation or platelet function disorder (not related to thrombocytopenia), eg, von Willebrand's disease Other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Myocardial infarction within 6 months of enrolment date Uncontrolled angina or congestive heart failure within 3 months of enrolment date Left ventricular ejection fraction (LVEF) < 40% Significant cardiac conduction abnormality, including history of clinically-significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), history of third degree heart block or diagnosed congenital long QT syndrome, and/or prolonged QTc/f interval > 450 msec on baseline ECG.
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
- Patients unable or unwilling to give written, informed consent prior to study participation.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
Institut Catalá d'Oncologia L'Hospitallet
Barcelona, Barcelona, 08907
Hospital de León
León, León, 24071
Hospital San Pedro de La Rioja
Logroño, La Rioja, 26006
Hospital Universitario de la Princesa
Madrid, Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, Castille-La Mancha, 45004
Hospital POVISA
Vigo, Pontevedra, 36211
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01010
About this study
Official title: Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment
Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
Read the detailed description
This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib.
All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first. Patients will undergo BCR-ABL assessments at study entry and every 3 months (central lab) and immunophenotyping and studies for clonal lymphocytosis at study entry, at 3 and 6 months.
Cytogenetic assessment will be done only if loss of response/progression/clonal evolution are suspected.
Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis data will be collected for all patients and separate description for efficacy and safety parameters will be done in patients with and without lymphocytosis.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib (Sprycel) | Experimental | Dasatinib (Sprycel): 100 mg QD administered orally as continuous daily dosing (CDD)until disease progression or adverse events that, by protocol definition or Investigator judgment, would preclude further treatment with dasatinib Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asses the efficacy
To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600
Measured: 1 year
Secondary outcomes (2)
Asses the efficacy
To assess the efficacy of dasatinib in terms of depth and kinetics of molecular response
Measured: 1 year
Assess the relationship of dasatinib with the appearance of large granular lymphocytes
To assess the relationship of dasatinib with the appearance of large granular lymphocytes and assess the relationship of LGL with efficacy and toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Dynamic Solutions, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Steegmann Juan Luis, Dr, Study chair, PETHEMA FoundationGarcía Valentín, Dr, Study chair, PETHEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802450
- Sponsor's protocol ID
- DASAPOST
- Acronym
- DASAPOST
- Status last verified
- Sep 2015
- First submitted
- 27 Feb 2013
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment
- ClinicalTrials.gov ID
- NCT01802450
- Acronym / sponsor ID
- DASAPOST / DASAPOST
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Collaborators
- Dynamic Solutions, Bristol-Myers Squibb
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Mar 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.
Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
Detailed description
This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib.
All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first. Patients will undergo BCR-ABL assessments at study entry and every 3 months (central lab) and immunophenotyping and studies for clonal lymphocytosis at study entry, at 3 and 6 months.
Cytogenetic assessment will be done only if loss of response/progression/clonal evolution are suspected.
Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis data will be collected for all patients and separate description for efficacy and safety parameters will be done in patients with and without lymphocytosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib (Sprycel) | Experimental | Drug: DasatinibDasatinib (Sprycel): 100 mg QD administered orally as continuous daily dosing (CDD)until disease progression or adverse events that, by protocol definition or Investigator judgment, would preclude further treatment with dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients >or = 18 years
- Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase
- Treated with Imatinib 400 mg per day or 600 mg per day for at least 18 months. A wash out period of at least 7 days for imatinib is required prior to dasatinib administration
- Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response
- Ability to understand and voluntarily sign the informed consent for
Key exclusion criteria (14 listed)
- Patients treated with Imatinib at a dose different of 400/600 mg per day
- Patients treated with other TKI than imatinib
- Loss of cytogenetic response at study entry
- ECOG ≥ 3
- Inadequate bone marrow reserve: ANC <1.5 x 109/L and/or Platelet count < 100 x 109/L
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 |
|---|---|---|
| Dasatinib | Drug | Dasatinib (Sprycel) |
Primary outcome
Asses the efficacy
Time frame: 1 year
To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600
2 secondary outcomes
Asses the efficacy
Time frame: 1 year
Assess the relationship of dasatinib with the appearance of large granular lymphocytes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Dynamic Solutions CROLink provided by the sponsor.
- Bristol Myers SquibbLink provided by the sponsor.
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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.
Steegmann Juan Luis, Dr study chair
PETHEMA Foundation
García Valentín, Dr study chair
PETHEMA Foundation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia, run by PETHEMA Foundation at 15 sites in Spain.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
Results are not available in the source record.
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?
Asses the efficacy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2015.