Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy (FORTIS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia
• Intervention / Treatment: Other: Usual Practice; Other: Telephone Intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bayonne, France, 64109
    • Centre Hospitalier de la côte Basque
  • Perpignan, France, 66046
    • CH Saint Jean
  • Toulouse, France, 31059
    • CHU Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.
3. Signed informed consent
4. Age> or equal 18 years, ECOG PS 0-2.
5. Estimated overall survival>6 months.
6. Conserved liver function (bilirubin<2,5mg/dl, SGPT<4ULN, SGOT<4ULN) except infiltration due to the disease.
7. Contraception for younger patients.
8. Confident with the use of telephone, no disabling deafness.

Exclusion Criteria:

1. Richter syndrome or atypical CLL (Matutes score <4), and/or del17p by FISH
2. Relapse of CLL
3. Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance<30 ml/mn.
4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection
5. Previous history of hypersensibility to any product used in this protocol
6. Denial, or medical or psychological condition preventing completion of the signed informed consent.
7. Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study.
8. Pregnant/breastfeeding women.
9. CNS involvement by CLL.
10. Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Without AMA; Patient will be follow only like usual practice	Other: Usual Practice; None, only usual practice.
Other: With AMA; Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.	Other: Telephone Intervention; Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Loïc YSEBAERT, MD, University Hospital of Toulouse

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimated): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: 1030903; 2011-A00728-33 (Other Identifier: French ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO