Lymphoma, B-CellNCT03681938
Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission?
An observational study of Lymphoma, B-Cell, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Autograft
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2017to 28 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With High Risk Big B Cells Lymphoma
Who may be able to join
- Patients with High Risk Big B Cells Lymphoma
- Age > 18 years
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission After 2 Cycles of Chemotherapy ?
The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Recently, the use of early TEP (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. Nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion.
This institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.
- Conditions
- Lymphoma, B-Cell
- Being tested
- Autograft
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutograftProcedure or surgery
Autograft
| Study group | Role | What they receive |
|---|---|---|
| Intensification treatment: Autograft | Not described Receives: Procedure: Autograft | |
| Standard chemotherapy (without autograft) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the survival without progress of transplanted patients versus not transplanted patients
Medical follow up
Measured: From the date of complete remission post C2 of chemotherapy up to 120 months
Secondary outcomes (2)
Cumulative Relapse Incidence
Medical follow up
Measured: From the date of complete remission post C2 of chemotherapy up to 120 months
Overall survival
Medical follow up
Measured: From the date of complete remission post C2 of chemotherapy up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start3 Jul 2017
- Primary completion28 Jul 2019 (estimated)
- Study completion28 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOUABDALLAH Réda, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681938
- Sponsor's protocol ID
- ALERT-IPC 2017-015
- Status last verified
- Sep 2018
- First submitted
- 26 Oct 2017
- Last updated
- 24 Sep 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 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission After 2 Cycles of Chemotherapy ?
- ClinicalTrials.gov ID
- NCT03681938
- Acronym / sponsor ID
- ALERT-IPC 2017-015
- Conditions
- Lymphoma, B-Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 28 Jul 2019 (estimated)
- Study completion
- 28 Jul 2019 (estimated)
- First posted
- 24 Sep 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.
The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Recently, the use of early TEP (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. Nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion.
This institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensification treatment: Autograft | – | Procedure: Autograft |
| Standard chemotherapy (without autograft) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With High Risk Big B Cells Lymphoma
Key inclusion criteria (2 listed)
- Patients with High Risk Big B Cells Lymphoma
- Age > 18 years
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 |
|---|---|---|
| AutograftAutograft | Procedure or surgery | Intensification treatment: Autograft |
Primary outcome
Compare the survival without progress of transplanted patients versus not transplanted patients
Time frame: From the date of complete remission post C2 of chemotherapy up to 120 months
Medical follow up
2 secondary outcomes
Cumulative Relapse Incidence
Time frame: From the date of complete remission post C2 of chemotherapy up to 120 months
Overall survival
Time frame: From the date of complete remission post C2 of chemotherapy up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Institut paoli-calmettesLink provided by the sponsor.
- 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.
BOUABDALLAH Réda, MD 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 Lymphoma, B-Cell, 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 2 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 24 Sep 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?
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?
Compare the survival without progress of transplanted patients versus not transplanted patients (time frame: From the date of complete remission post C2 of chemotherapy up to 120 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 24 Sep 2018.