Lymphoblastic Leukemia, AcuteEWALL_OBSNCT02888977
Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL
An observational study of Lymphoblastic Leukemia, Acute, run by Versailles Hospital at 3 sites in France.
Trial summary
The use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lymphoblastic Leukemia, Acute
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2012to Dec 2022
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: All consecutive previously untreated patients aged 55 years and over with Philadelphia positive acute lymphoblastic leukaemia (Ph+ ALL) not included in a prospective clinical trial and treated with the combination of TKIs and low-intensity chemotherapy (EWALL backbone see Appendix 1) should be recorded in each center.
Who may be able to join
- Male or female patients ≥ 55 years
- Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
- Not included in a prospective clinical trial
- Treatment with the combination of tyrosine kinase inhibitors and low dose chemotherapy as recommended by the EWALL group (EWALL backbone).
Who cannot join
- 1. Patients deceded and having previously refused data collection.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CH Versailles
Le Chesnay, 78150
Rousselot Philippe, MD
- Recruiting
CHU Nimes
Nîmes
JOURDAN Eric
- Recruiting
CH Reims
Reims
About this study
Official title: An Observatory for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL) and Treated With the Combination of Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy.
The use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+ ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with low-intensity chemotherapy is currently initiated within the EWALL centers.
- The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01 study it could be anticipated that 50 to 100 patients aged more than 55 years will be diagnosed during this 6 months period of time. In addition, all the EWALL centers are not participating to the EWALL-PH-02 study and thus these centers could be offered to treat patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be defined in order to collect the data of the patients treated following the EWALL-PH imatinib study. The main recommendation is to follow as close as possible the procedures of the EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set. This imatinib treated cohort of patients would be of particular importance in order to better define the potential benefit of using one TKI compared to one other. From the end of the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were treated following the common backbone schedule in combination with imatinib or others TKI. Patients not included in clinical trials for other reasons were also offered a treatment with the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory retrospective and prospective is to describe the efficacy and the tolerance of the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.
- Conditions
- Lymphoblastic Leukemia, Acute
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point will be Progression Free Survival (PFS) rate at 12 months
Measured: 12 months
Secondary outcomes (10)
The proportion of Complete haematological remission
Measured: 12 months
The proportion of Major molecular response defined by a BCR-ABL/ABL ≤ 0.1% in bone marrow
Measured: 12 months
The proportion of Complete molecular response
Measured: 12 months
Event free survival
Measured: 12 months
Relapse free survival
Measured: 12 months
Progression free survival
Measured: 12 months
The proportion of Detection of a T315I or F317 BCR-ABL TK mutation
Measured: 12 months
The proportion of molecular progression defined by the loss of major molecular response
Measured: 12 months
Overall survival
Measured: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe ROUSSELOT, Versailles Hospital
- Investigators
- Rousselot philippe, MD, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888977
- Sponsor's protocol ID
- 12/13_ EWALL Obs
- Acronym
- EWALL_OBS
- Status last verified
- Jul 2018
- First submitted
- 19 Aug 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observatory for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL) and Treated With the Combination of Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy.
- ClinicalTrials.gov ID
- NCT02888977
- Acronym / sponsor ID
- EWALL_OBS / 12/13_ EWALL Obs
- Conditions
- Lymphoblastic Leukemia, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Sep 2016 (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.
The use of imatinib in combination with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+ ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with low-intensity chemotherapy is currently initiated within the EWALL centers.
- The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01 study it could be anticipated that 50 to 100 patients aged more than 55 years will be diagnosed during this 6 months period of time. In addition, all the EWALL centers are not participating to the EWALL-PH-02 study and thus these centers could be offered to treat patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be defined in order to collect the data of the patients treated following the EWALL-PH imatinib study. The main recommendation is to follow as close as possible the procedures of the EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set. This imatinib treated cohort of patients would be of particular importance in order to better define the potential benefit of using one TKI compared to one other. From the end of the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were treated following the common backbone schedule in combination with imatinib or others TKI. Patients not included in clinical trials for other reasons were also offered a treatment with the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory retrospective and prospective is to describe the efficacy and the tolerance of the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All consecutive previously untreated patients aged 55 years and over with Philadelphia positive acute lymphoblastic leukaemia (Ph+ ALL) not included in a prospective clinical trial and treated with the combination of TKIs and low-intensity chemotherapy (EWALL backbone see Appendix 1) should be recorded in each center.
Key inclusion criteria (4 listed)
- Male or female patients ≥ 55 years
- Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
- Not included in a prospective clinical trial
- Treatment with the combination of tyrosine kinase inhibitors and low dose chemotherapy as recommended by the EWALL group (EWALL backbone).
Key exclusion criteria (1 listed)
- 1. Patients deceded and having previously refused data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary end-point will be Progression Free Survival (PFS) rate at 12 months
Time frame: 12 months
10 secondary outcomes
The proportion of Complete haematological remission
Time frame: 12 months
The proportion of Major molecular response defined by a BCR-ABL/ABL ≤ 0.1% in bone marrow
Time frame: 12 months
The proportion of Complete molecular response
Time frame: 12 months
Event free survival
Time frame: 12 months
Relapse free survival
Time frame: 12 months
Progression free survival
Time frame: 12 months
The proportion of Detection of a T315I or F317 BCR-ABL TK mutation
Time frame: 12 months
The proportion of molecular progression defined by the loss of major molecular response
Time frame: 12 months
Overall survival
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Rousselot philippe, MD principal investigator
CH Versailles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoblastic Leukemia, Acute, run by Versailles Hospital at 3 sites in France.
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 4 inclusion and 1 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
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?
Contact Morisset Laure (0139239785, lmorisset@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point will be Progression Free Survival (PFS) rate at 12 months (time frame: 12 months). 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 30 Jul 2018.