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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT01393366

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Other: Telephone Intervention Other: Usual Practice	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evaluation of RDI [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier de la côte basque	Bayonne	France	64109
2	CH Saint Jean	Perpignan	France	66046
3	CHU Purpan	Toulouse	France	31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Loïc YSEBAERT, MD, University Hospital Of Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT01393366

Other Study ID Numbers:

1030903

First Posted:

Jul 13, 2011

Last Update Posted:

Jul 29, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Jul 29, 2020