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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393366
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Other: Telephone Intervention Other: Usual Practice Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
Study Start Date : September 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Arm Intervention/treatment
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 '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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Evaluation of Toxicity grade III-IV [ Time Frame: 3 years ]
    rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393366

Centre Hospitalier de la côte basque
Bayonne, France, 64109
CH Saint Jean
Perpignan, France, 66046
CHU Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Loïc YSEBAERT, MD University Hospital Of Toulouse

Responsible Party: University Hospital, Toulouse Identifier: NCT01393366     History of Changes
Other Study ID Numbers: 1030903
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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