LymphomaAMANCT03336138
Application of Telemedicine to the Management of Aggressive Lymphomas
A study testing AMA (Assistance for ambulatory patients) in people with Lymphoma, run by University Hospital, Toulouse at 10 sites in France.
Trial summary
The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- AMA (Assistance for ambulatory patients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2012to 31 Jan 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
- a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
- Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
- accepting the study
Who cannot join
- Patient with another type of lymphoma (including transformed follicular forms)
- Patient having already started his treatment.
- Life expectancy <3 months.
- Carcinologic history
- Serum positive for HIV or hepatitis B virus (HBV).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Clinique Claude Bernard
Albi, 81000
Hospital
Auch, 32000
Bayonne Hospital
Bayonne, 64000
University Hospital Bordeaux
Bordeaux, 33000
Hospital
Montauban, 82000
Clinique Marzet
Pau, 64000
Rodez Hospital
Rodez, 12000
Tarbes Hospital
Tarbes, 65000
University Hospital of Toulouse
Toulouse, France
Clinique Saint Jean
Toulouse, 31000
About this study
Official title: Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.
- Conditions
- Lymphoma
- Being tested
- AMA (Assistance for ambulatory patients)
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA (Assistance for ambulatory patients)Other
telephone follow-up modality
| Study group | Role | What they receive |
|---|---|---|
| AMA group | Active comparator | Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients) Receives: Other: AMA (Assistance for ambulatory patients) |
| Control group | No intervention | Patient with standard follow-up with no specific assistance for ambulatory patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-relative intensity (RDI)
reduction of RDI
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study startJan 2012
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT Guy, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336138
- Sponsor's protocol ID
- RC31/12/0072
- Acronym
- AMA
- Status last verified
- Apr 2019
- First submitted
- 30 Oct 2017
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lamy S, Bettiol C, Grosclaude P, Compaci G, Albertus G, Recher C, Nogaro JC, Despas F, Laurent G, Delpierre C. The care center influences the management of lymphoma patients in a universal health care system: an observational cohort study. BMC Health Serv Res. 2016 Aug 2;16(a):336. doi: 10.1186/s12913-016-1553-9.
PubMed 27485349Borel C, Lamy S, Compaci G, Recher C, Jeanneau P, Nogaro JC, Bauvin E, Despas F, Delpierre C, Laurent G. A longitudinal study of non-medical determinants of adherence to R-CHOP therapy for diffuse large B-cell lymphoma: implication for survival. BMC Cancer. 2015 Apr 15;15:288. doi: 10.1186/s12885-015-1287-9.
PubMed 25884669
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
- ClinicalTrials.gov ID
- NCT03336138
- Acronym / sponsor ID
- AMA / RC31/12/0072
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Nov 2017 (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 purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMA group | Active comparator | Other: AMA (Assistance for ambulatory patients)Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients) |
| Control group | No intervention | –Patient with standard follow-up with no specific assistance for ambulatory patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
- a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
- Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
- accepting the study
Key exclusion criteria (5 listed)
- Patient with another type of lymphoma (including transformed follicular forms)
- Patient having already started his treatment.
- Life expectancy <3 months.
- Carcinologic history
- Serum positive for HIV or hepatitis B virus (HBV).
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 |
|---|---|---|
| AMA (Assistance for ambulatory patients)telephone follow-up modality | Other | AMA group |
Primary outcome
dose-relative intensity (RDI)
Time frame: through study completion, an average of 2 years
reduction of RDI
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 15 Dec 2025.
- Results publication: PubMed 27485349Lamy S, Bettiol C, Grosclaude P, Compaci G, Albertus G, Recher C, Nogaro JC, Despas F, Laurent G, Delpierre C. The care center influences the management of lymphoma patients in a universal health care system: an observational cohort study. BMC Health Serv Res. 2016 Aug 2;16(a):336. doi: 10.1186/s12913-016-1553-9.
- Results publication: PubMed 25884669Borel C, Lamy S, Compaci G, Recher C, Jeanneau P, Nogaro JC, Bauvin E, Despas F, Delpierre C, Laurent G. A longitudinal study of non-medical determinants of adherence to R-CHOP therapy for diffuse large B-cell lymphoma: implication for survival. BMC Cancer. 2015 Apr 15;15:288. doi: 10.1186/s12885-015-1287-9.
- 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.
LAURENT Guy, MD principal investigator
University Hospital, Toulouse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMA (Assistance for ambulatory patients) in people with Lymphoma, run by University Hospital, Toulouse at 10 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 5 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
dose-relative intensity (RDI) (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336138, which also lists 2 linked publications.
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 15 Dec 2025.