NCT01393366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 1, 2026

Status Verified

July 1, 2020

Enrollment Period

4.3 years

First QC Date

July 5, 2011

Last Update Submit

March 31, 2026

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of Toxicity grade III-IV

    3 years

Study Arms (2)

Without AMA

OTHER

Patient will be follow only like usual practice

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.

Other: Telephone Intervention

Interventions

Telephone InterventionOTHER

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

With AMA
Usual PracticeOTHER

None, only usual practice.

Without AMA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier de la côte basque

Bayonne, 64109, France

Location

CH Saint Jean

Perpignan, 66046, France

Location

CHU Purpan

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 30778715RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Loïc YSEBAERT, MD

    University Hospital Of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 13, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

April 1, 2026

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)