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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telephone Intervention
Usual Practice
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre Hospitalier de la côte basque
  • CH Saint Jean
  • CHU Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Without AMA

With AMA

Arm Description

Patient will be follow only like usual practice

Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 5, 2011
Last Updated
July 28, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01393366
Brief Title
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
Acronym
FORTIS
Official Title
Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without AMA
Arm Type
Other
Arm Description
Patient will be follow only like usual practice
Arm Title
With AMA
Arm Type
Other
Arm Description
Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.
Intervention Type
Other
Intervention Name(s)
Telephone Intervention
Intervention Description
Only for arm AMA, patient will have one phone every week to evaluate physical conditions.
Intervention Type
Other
Intervention Name(s)
Usual Practice
Intervention Description
None, only usual practice.
Primary Outcome Measure Information:
Title
Evaluation of RDI
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Evaluation of Toxicity grade III-IV
Description
rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT, MD
Organizational Affiliation
University Hospital Of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de la côte basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
CH Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30778715
Citation
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.
Results Reference
result

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

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