Acute Lymphoblastic LeukemiaEQUAALL01NCT04677231
Evaluation of Long-term Health Status and Quality of Life in Adult Survivors With Philadelphia-negative Acute Lymphoblastic Leukemia/Lymphoma Treated With an Intensive Pediatric or Pediatric-inspired Protocol
An observational study of Acute Lymphoblastic Leukemia and Acute Lymphoblastic Lymphoma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Lymphoblastic Lymphoma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Mar 2024
- 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 25 to 70 years
- All sexes
- Adult, Older adult
Study population: Adult patients aged 15-59y at diagnosis treated ten years ago for a Ph1-negative acute lymphoblastic leukemia/lymphoma (ALL/LL)
Who may be able to join
- Patient with Philadelphia-negative ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
- Patients older than 15 years old and less than 60 years old at diagnosis
- Patient with a follow-up from first complete remission of more than 10 years,
- Patient who gave informed signed consent for baseline examination
Who cannot join
- Patient who experienced ALL/LL relapse within the 5 past years.
- Philadelphia positive ALL patients
Trial locations and contacts
No sites are listed yet.
About this study
The overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. This approach led to a global improvement in overall survival (5y-OS, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-TRM in patients > 45y, 19%). Pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. This study aims to evaluate the impact in term of long-term events and QoL in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. The main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for ALL/LL with an intensified pediatric-inspired protocol (GRAALL2003/05-LL03-FRALLE2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. One of the secondary endpoint of the study is to assess quality of life of these patients.
- 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.
Prevalence of adverse events
This is a binary, composite, endpoint, including any of the following adverse events:
- metabolic troubles (dysmetabolic syndrome, dyslipidemia, diabetes)
- osseous events /osteoporosis
- cardiac and vascular troubles
- neurologic troubles
- lung dysfunctions
- endocrinal troubles
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Secondary outcomes (7)
Prevalence of metabolic troubles
Metabolic troubles will be defined as dysmetabolic syndrome or dyslipidemia or diabetes
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of osseous events
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of cardiac and vascular troubles
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of neurologic troubles
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of lung dysfunctions
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of endocrinal troubles
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Quality of Life
Quality of life will be assess using the SF36-questionnaire. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are grouped into three categories: functional status, well-being, overall health assessment. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). For each dimension, the scores for the different items are coded and then summed and transformed linearly on a scale ranging from 0 to 100. A physical composite score and a mental composite score can be calculated according to an established algorithm
Measured: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677231
- Sponsor's protocol ID
- P150969J
- Acronym
- EQUAALL01
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Health Status and Quality of Life in Adult Survivors With Philadelphia-negative Acute Lymphoblastic Leukemia/Lymphoma Treated With an Intensive Pediatric or Pediatric-inspired Protocol
- ClinicalTrials.gov ID
- NCT04677231
- Acronym / sponsor ID
- EQUAALL01 / P150969J
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Dec 2020 (actual)
- 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 overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. This approach led to a global improvement in overall survival (5y-OS, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-TRM in patients > 45y, 19%). Pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. This study aims to evaluate the impact in term of long-term events and QoL in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. The main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for ALL/LL with an intensified pediatric-inspired protocol (GRAALL2003/05-LL03-FRALLE2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. One of the secondary endpoint of the study is to assess quality of life of these patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 15-59y at diagnosis treated ten years ago for a Ph1-negative acute lymphoblastic leukemia/lymphoma (ALL/LL)
Key inclusion criteria (4 listed)
- Patient with Philadelphia-negative ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
- Patients older than 15 years old and less than 60 years old at diagnosis
- Patient with a follow-up from first complete remission of more than 10 years,
- Patient who gave informed signed consent for baseline examination
Key exclusion criteria (2 listed)
- Patient who experienced ALL/LL relapse within the 5 past years.
- Philadelphia positive ALL patients
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
Prevalence of adverse events
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
This is a binary, composite, endpoint, including any of the following adverse events: * metabolic troubles (dysmetabolic syndrome, dyslipidemia, diabetes) * osseous events /osteoporosis * cardiac and vascular troubles * neurologic troubles * lung dysfunctions * endocrinal troubles
7 secondary outcomes
Prevalence of metabolic troubles
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of osseous events
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of cardiac and vascular troubles
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of neurologic troubles
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of lung dysfunctions
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Prevalence of endocrinal troubles
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Quality of Life
Time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Acute Lymphoblastic Lymphoma, run by Assistance Publique - Hôpitaux de Paris.
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 2 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 21 Dec 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.
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 Nicolas BOISSEL, Pr (+33142499643, nicolas.boissel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of adverse events (time frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.). 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 21 Dec 2020.