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

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01393366
First received: July 5, 2011
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
 Other: Telephone Intervention
Other: Usual Practice
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Evaluation of RDI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Without AMA
Patient will be follow only like usual practice
 Other: Usual Practice
None, only usual practice.
With AMA
Patient will be follow like usual practice, plus one phone 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393366

Locations
France
Centre Hospitalier de la côte basque Recruiting
Bayonne, France, 64109
Contact: Anne BANOS, MD         abanos@ch-cotebasque.fr    
Principal Investigator: Anne BANOS, MD            
CH Saint Jean Not yet recruiting
Perpignan, France, 66046
Contact: Laurence SANHES, MD         laurence.sanhes@ch-perpignan.fr    
Principal Investigator: Laurence SANHES, MD            
CHU Purpan Recruiting
Toulouse, France, 31059
Contact: Loïc YSEBAERT, MD         ysebaert.l@chu-toulouse.fr    
Principal Investigator: Loïc YSEBAERT, MD            
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Loïc YSEBAERT, MD University Hospital Of Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01393366     History of Changes
Other Study ID Numbers: 1030903
Study First Received: July 5, 2011
Last Updated: April 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013