Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
1 other identifier
observational
41
1 country
15
Brief Summary
The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).
- at diagnosis
- after the first cycle of CHOEP (early evaluation)
- at the end of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2018
Longer than P75 for all trials
15 active sites
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 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedSeptember 26, 2023
September 1, 2023
4.9 years
July 18, 2018
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
Day 0
Secondary Outcomes (11)
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
1 month
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
2 years
Prognostic value of biological parameters on the incidence of relapse
Day 0
Prognostic value of biological parameters on the incidence of relapse
1 month
Prognostic value of biological parameters on the incidence relapse
2 years
- +6 more secondary outcomes
Eligibility Criteria
Adult Anaplastic large-cell lymphoma ALK+
You may qualify if:
- Over 18 years old Diagnosed with Anaplastic large-cell lymphoma ALK+
- Planned treatment : 6 cycles of CHOEP 21
- Planned lumbar puncture at diagnosis or at the first cycle with intrathecal prophylaxis with methotrexate (15 mg) at the first cycle
- Planned interim positron emission tomograph (PET)-scan after 3 cycles of treatment and at the end of treatment according to the center standard of care
You may not qualify if:
- Involvement of the central nervous system
- Intent of Autologous stem-cell transplant in first line
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Lymphoma Academic Research Organisationlead
- Hôpital Necker-Enfants Maladescollaborator
- Fondation ARCcollaborator
- Pfizercollaborator
- Takedacollaborator
Study Sites (15)
CHU Amiens - Hôpital Sud
Amiens, France
CHU d'Estaing
Clermont-Ferrand, France
APHP - Hopital Henri Mondor
Créteil, France
CHU Grenoble
Grenoble, France
CHRU de Lille - Hôpital Claude Huriez
Lille, France
Institut Paoli Calmette
Marseille, France
APHP - Hôpital Necker
Paris, France
APHP - Hôpital Saint Louis
Paris, France
CHU Bordeaux - Centre François Magendie
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU de Rennes - Hôpital de Pontchaillou
Rennes, France
Centre Henri Becquerel
Rouen, France
CHRU de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
CHU Brabois
Vandœuvre-lès-Nancy, France
Related Publications (4)
Sibon D, Fournier M, Briere J, Lamant L, Haioun C, Coiffier B, Bologna S, Morel P, Gabarre J, Hermine O, Sonet A, Gisselbrecht C, Delsol G, Gaulard P, Tilly H. Long-term outcome of adults with systemic anaplastic large-cell lymphoma treated within the Groupe d'Etude des Lymphomes de l'Adulte trials. J Clin Oncol. 2012 Nov 10;30(32):3939-46. doi: 10.1200/JCO.2012.42.2345. Epub 2012 Oct 8.
PMID: 23045585BACKGROUNDDamm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2.
PMID: 24297868BACKGROUNDDamm-Welk C, Pillon M, Woessmann W, Mussolin L. Prognostic factors in paediatric anaplastic large cell lymphoma: role of ALK. Front Biosci (Schol Ed). 2015 Jun 1;7(2):205-16. doi: 10.2741/S434.
PMID: 25961696BACKGROUNDLamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugieres L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.
PMID: 22084369BACKGROUND
Biospecimen
Serum, plasma, constitutional DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David SIBON, MD
Hôpital Necker-Enfants Malades
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2018
First Posted
July 27, 2018
Study Start
August 2, 2018
Primary Completion
June 16, 2023
Study Completion
June 16, 2023
Last Updated
September 26, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share