Chronic Lymphocytic LeukemiaFORTISNCT01393366
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
A study testing Telephone Intervention and Usual Practice in people with Chronic Lymphocytic Leukemia, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Telephone Intervention and Usual Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2011to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.
- Matutes score must be 4-5/5.
- Initial cytopenia (due to CLL) are not exclusion criteria.
- Lymph node biopsy is needed only if suspicion of Richter syndrome.
- Mandatory pre-therapeutic check-up: FISH in search for deletion del17p and del11q, DAT test, haptoglobin levels, creatinine clearance.
- Eligibility to a treatment with FCR: clearance > 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.
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- Signed informed consent
- Age> or equal 18 years, ECOG PS 0-2.
- Estimated overall survival>6 months.
- Conserved liver function (bilirubin<2,5mg/dl, SGPT<4ULN, SGOT<4ULN) except infiltration due to the disease.
- Contraception for younger patients.
- Confident with the use of telephone, no disabling deafness.
Who cannot join
- Richter syndrome or atypical CLL (Matutes score <4), and/or del17p by FISH
- Relapse of CLL
- Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance<30 ml/mn.
- Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection
- Previous history of hypersensibility to any product used in this protocol
- Denial, or medical or psychological condition preventing completion of the signed informed consent.
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- Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study.
- Pregnant/breastfeeding women.
- CNS involvement by CLL.
- Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier de la côte basque
Bayonne, 64109
CH Saint Jean
Perpignan, 66046
CHU Purpan
Toulouse, 31059
About this study
Official title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Telephone Intervention, Usual Practice
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone InterventionOther
Only for arm AMA, patient will have one phone every week to evaluate physical conditions.
Usual PracticeOther
None, only usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Without AMA | Other | Patient will be follow only like usual practice Receives: Other: Usual Practice |
| With AMA | Other | Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions. Receives: Other: Telephone Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of RDI
Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.
Measured: 3 years
Secondary outcomes (1)
Evaluation of Toxicity grade III-IV
rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc YSEBAERT, MD, Principal investigator, University Hospital Of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393366
- Sponsor's protocol ID
- 1030903
- Other IDs
- 2011-A00728-33
- Acronym
- FORTIS
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2011
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18.
PubMed 30778715
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
- ClinicalTrials.gov ID
- NCT01393366
- Acronym / sponsor ID
- FORTIS / 1030903
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jul 2011 (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 investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without AMA | Other | Other: Usual PracticePatient will be follow only like usual practice |
| With AMA | Other | Other: Telephone InterventionPatient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.
- Eligibility to a treatment with FCR: clearance > 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.
- Signed informed consent
- Age> or equal 18 years, ECOG PS 0-2.
- Estimated overall survival>6 months.
Key exclusion criteria (10 listed)
- Richter syndrome or atypical CLL (Matutes score <4), and/or del17p by FISH
- Relapse of CLL
- Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance<30 ml/mn.
- Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection
- Previous history of hypersensibility to any product used in this protocol
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 |
|---|---|---|
| Telephone InterventionOnly for arm AMA, patient will have one phone every week to evaluate physical conditions. | Other | With AMA |
| Usual PracticeNone, only usual practice. | Other | Without AMA |
Primary outcome
Evaluation of RDI
Time frame: 3 years
Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.
1 secondary outcome
Evaluation of Toxicity grade III-IV
Time frame: 3 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 1 Apr 2026.
- Results publication: PubMed 30778715Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18.
- 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.
Loïc YSEBAERT, MD principal investigator
University Hospital Of Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Intervention and Usual Practice in people with Chronic Lymphocytic Leukemia, run by University Hospital, Toulouse 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 12 inclusion and 10 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 1 Apr 2026. 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?
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?
Evaluation of RDI (time frame: 3 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 NCT01393366, which also lists 1 linked publication.
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 1 Apr 2026.