Malignant HaemopathiesHEMAJANCT03469921
Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016
An observational study of Malignant Haemopathies and Acute Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016 Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Malignant Haemopathies, Acute Leukemia, Non-hodgkin Lymphoma
- What is being tested?
- administered therapeutic regimens
- How many people
- 602 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2000to 31 Dec 2016
- 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 15 to 30 years
- All sexes
- Child, Adult
Study population: cohort of young adult patients and adolescents aged 15 to 30, carriers of hematological malignancies, and supported between 2000 and 2016
Who may be able to join
- Malignant hemopathies (acute leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma) in primary care between 2000 and 2016.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016
Read the detailed description
The therapeutic results (response and survival) of young adult and adolescent patients with hematological malignancies are generally lower than those usually observed in adults over the age of 30, with equivalent treatment, particularly in lymphomatous pathology.The overall analysis of this large cohort of patients in its entirety, then by age groups (15-17 years, 18-25 years, 26-30 years) and pathology aims to describe the future of patients and patients. compare them to the results of the literature observed in this age group, and according to the therapeutic regimens administered (pediatric regimen or adult regimen).
- Being tested
- administered therapeutic regimens
- Keywords
- Malignant haemopathies, Acute Leukemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Young adults, Adolescent
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administered therapeutic regimensDrug
administered therapeutic regimens
| Study group | Role | What they receive |
|---|---|---|
| 15-17 years old | 15-17 years old Receives: Drug: administered therapeutic regimens | |
| 18-25 years old | 18-25 years old Receives: Drug: administered therapeutic regimens | |
| 26-30 years old | 26-30 years old Receives: Drug: administered therapeutic regimens | |
| acute leukemia | acute leukemia Receives: Drug: administered therapeutic regimens | |
| non-Hodgkin's lymphoma | non-Hodgkin's lymphoma Receives: Drug: administered therapeutic regimens | |
| Hodgkin lymphoma | Hodgkin lymphoma Receives: Drug: administered therapeutic regimens | |
| pediatric therapeutic regimen administered | pediatric therapeutic regimen administered Receives: Drug: administered therapeutic regimens | |
| adult therapeutic regimen administered | adult therapeutic regimen administered Receives: Drug: administered therapeutic regimens | |
| patients included in clinical trials | patients included in clinical trials Receives: Drug: administered therapeutic regimens | |
| patients not included in clinical trials | patients not included in clinical trials Receives: Drug: administered therapeutic regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Survival
delay between the date of diagnosis and the date of the latest news
Measured: 15 years
Survival without event
delay between the date of diagnosis and an event (relapse, death, lost of follow-up)
Measured: 15 years
Progression-free survival
defined as the delay between the date of diagnosis and the date of relapse or death.
Measured: 15 years
Secondary outcomes (7)
Epidemiological distribution by pathology compared to the adult population over 30 years
Epidemiological distribution by pathology compared to the adult population over 30 years
Measured: 1 day
Descriptive analysis of the characteristics of the disease at diagnosis by pathology
Descriptive analysis of the characteristics of the disease at diagnosis by pathology
Measured: 15 years
Descriptive analysis of treatments by pathology
Descriptive analysis of treatments by pathology
Measured: 15 years
Overall survival (OS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Overall survival (OS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Measured: 15 years
Event-free survival (EFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Event-free survival (EFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Measured: 15 years
Progression-free survival (PFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Progression-free survival (PFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Measured: 15 years
Long-term toxicity analysis (second cancers, fertility) for the global cohort and pathology.
Long-term toxicity analysis (second cancers, fertility) for the global cohort and pathology.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Jan 2000
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HaemopathiesStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane COSO, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469921
- Sponsor's protocol ID
- HEMAJA-IPC 2017-045
- Acronym
- HEMAJA
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016
- ClinicalTrials.gov ID
- NCT03469921
- Acronym / sponsor ID
- HEMAJA / HEMAJA-IPC 2017-045
- Keywords
- Malignant haemopathies, Acute Leukemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Young adults, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Mar 2018 (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.
Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016
Detailed description
The therapeutic results (response and survival) of young adult and adolescent patients with hematological malignancies are generally lower than those usually observed in adults over the age of 30, with equivalent treatment, particularly in lymphomatous pathology.The overall analysis of this large cohort of patients in its entirety, then by age groups (15-17 years, 18-25 years, 26-30 years) and pathology aims to describe the future of patients and patients. compare them to the results of the literature observed in this age group, and according to the therapeutic regimens administered (pediatric regimen or adult regimen).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 15-17 years old | – | Drug: administered therapeutic regimens15-17 years old |
| 18-25 years old | – | Drug: administered therapeutic regimens18-25 years old |
| 26-30 years old | – | Drug: administered therapeutic regimens26-30 years old |
| acute leukemia | – | Drug: administered therapeutic regimensacute leukemia |
| non-Hodgkin's lymphoma | – | Drug: administered therapeutic regimensnon-Hodgkin's lymphoma |
| Hodgkin lymphoma | – | Drug: administered therapeutic regimensHodgkin lymphoma |
| pediatric therapeutic regimen administered | – | Drug: administered therapeutic regimenspediatric therapeutic regimen administered |
| adult therapeutic regimen administered | – | Drug: administered therapeutic regimensadult therapeutic regimen administered |
| patients included in clinical trials | – | Drug: administered therapeutic regimenspatients included in clinical trials |
| patients not included in clinical trials | – | Drug: administered therapeutic regimenspatients not included in clinical trials |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- cohort of young adult patients and adolescents aged 15 to 30, carriers of hematological malignancies, and supported between 2000 and 2016
Key inclusion criteria (1 listed)
- Malignant hemopathies (acute leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma) in primary care between 2000 and 2016.
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| administered therapeutic regimensadministered therapeutic regimens | Drug | 15-17 years old, 18-25 years old, 26-30 years old, Hodgkin lymphoma, acute leukemia, adult therapeutic regimen administered, non-Hodgkin's lymphoma, patients included in clinical trials, patients not included in clinical trials, pediatric therapeutic regimen administered |
Primary outcome
Global Survival
Time frame: 15 years
delay between the date of diagnosis and the date of the latest news
Survival without event
Time frame: 15 years
delay between the date of diagnosis and an event (relapse, death, lost of follow-up)
Progression-free survival
Time frame: 15 years
defined as the delay between the date of diagnosis and the date of relapse or death.
7 secondary outcomes
Epidemiological distribution by pathology compared to the adult population over 30 years
Time frame: 1 day
Descriptive analysis of the characteristics of the disease at diagnosis by pathology
Time frame: 15 years
Descriptive analysis of treatments by pathology
Time frame: 15 years
Overall survival (OS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time frame: 15 years
Event-free survival (EFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time frame: 15 years
Progression-free survival (PFS) of patients included in clinical trials compared to patients not included for the overall cohort and pathology
Time frame: 15 years
Long-term toxicity analysis (second cancers, fertility) for the global cohort and pathology.
Time frame: 15 years
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 19 Mar 2018.
- Individual participant dataSharing planned: No
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.
Diane COSO principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Haemopathies and Acute Leukemia, run by Institut Paoli-Calmettes at 1 site 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 1 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: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Global Survival (time frame: 15 years). The study lists 3 primary outcomes in all. 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 19 Mar 2018.