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Etude : CALLS / INCB 84344-401 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CALLS / INCB 84344-401

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Cohort Study To Establish the Prevalence of Mutations in Patients With CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ ALL With Detectable BCR-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.

Study population:
Approximately 50 centers in the UK, Ireland and France that treat adult patients with CML and Ph+ ALL will be selected for participation in the study. The sites selected will be a mixture of hospital and academic centers.

The target study population will include adult patients with CML who meet the ELN criteria for warning or failure or have high SOKAL score > 0.8 or presence of additional chromosomal abnormalities (ACAs), all with detectable BCR-ABL levels. Ph+ ALL patients must have detectable BCR-ABL levels. Patients will be taking their first or subsequent TKI.

Consecutive patients within each prescriber's practice who meet the enrollment criteria and provide informed consent will be invited to enroll into the study.

Repeat NGS KD mutation testing is permitted under the protocol as deemed part of the standard management of patients.


Current primary outcome:
- Percentage of participants with any mutation [ Time Frame: Up to approximately 1 month per individual participant. ]. All samples will be processed by NGS.
- Frequency of all specific mutations [ Time Frame: Up to approximately 1 month per individual participant. ]. All samples will be processed by NGS.

Current secondary outcomes:
- Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [ Time Frame: Up to approximately 1 month per individual participant. ]
- Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [ Time Frame: Up to approximately 1 month per individual participant. ]
- Percentage of participants with individual mutations in Ph+ ALL [ Time Frame: Up to approximately 1 month per individual participant. ]
- Frequency of individual mutations in Ph+ ALL [ Time Frame: Up to approximately 1 month per individual participant. ]
- Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI [ Time Frame: Up to approximately 1 month per individual participant. ]
- Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI [ Time Frame: Up to approximately 1 month per individual participant. ]
- Percentage of participants with individual mutations by BCR-ABL level [ Time Frame: Up to approximately 1 month per individual participant. ]
- Frequency of individual mutations by BCR-ABL level [ Time Frame: Up to approximately 1 month per individual participant. ]

Phase : NA

Stade : NA

1 (hémato), Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent TKI.
- Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:
* BCR-ABL/ABL IS transcripts > 10% at 3 months
* BCR-ABL/ABL IS transcripts > 1% at 6 months
* BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later
- Patients with CML must not currently be in MMR (ie, have disease with BCR-ABL1/ABL1 transcripts > 0.1% IS).

OR

- Patients with Ph+ ALL with any level of BCR-ABL/ABL IS transcripts. Patients with Ph+ ALL should have BCR-ABL1/ABL1 transcript levels > 0.1% and should not be currently enrolled in UKALL14 but may have relapsed during or after participation in UKALL14.
- Patients with an intermediate or high Sokal score (> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months.
- Patients with additional chromosomal abnormalities at diagnosis and patients with AP-CML may be recruited into the study, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months and beyond provided BCR-ABL1/ABL1 transcript levels are > 0.1% IS. It is recommended that these patients have mutational analysis performed every 3 months irrespective of BCR-ABL1/ABL1 transcript levels until they reach MR3/MMR (BCR-ABL1/ABL1 < 0.1% IS).
- Any patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results.
- Patients who have the ability to understand the requirements of the study and provide written informed consent.

Critères de non-inclusion : - Patients without detectable BCR-ABL
- patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines).
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03647215
Promoteur :
INCYTE
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Valérie Coiteux

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 20/01/2020