Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

NCT ID: NCT03603847

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2023-06-16

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

Detailed Description

ALK-positive anaplastic large cell (anaplastic large-cell lymphoma, ALCL) is a rare adult disease for which almost all published studies are retrospective. The overall survival (OS) at 5 years varies from 70 to 87%. A recent international pooled analysis showed that the International Prognostic Index (IPI) had good predictive value for the PFS and the OS.

In children, new prognostic factors have been identified: the titre of circulating anti-ALK antibodies (inverse correlation between the antibody titre and the prognosis), the detection of a NPM-ALK transcript in the blood at diagnosis (minimal disseminated disease, MDD); correlation between MDD positivity and pejorative prognosis) and its minimal residual disease (MRD), and the histological subtype (common versus small cells / lymphohistiocytic).

The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study.

• At diagnosis (before starting treatment):
• Cycle 2 Day 1 (before starting cycle 2 treatment):
• At the end of treatment evaluation:

40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively.

During a 2-year period, relapses / progressions and patient deaths will be monitored for the calculation of the incidence of relapse / progression, progression free survival (PFS) and overall survival (OS).

Conditions

Anaplastic Large Cell Lymphoma, ALK-Positive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Involvement of the central nervous system

Intent of Autologous stem-cell transplant in first line

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role: collaborator

Fondation ARC

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: collaborator

The Lymphoma Academic Research Organisation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David SIBON, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Necker-Enfants Malades

Locations

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

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 23045585 (View on PubMed)

Damm-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.

Reference Type: BACKGROUND

PMID: 24297868 (View on PubMed)

Damm-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.

Reference Type: BACKGROUND

PMID: 25961696 (View on PubMed)

Lamant 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.

Reference Type: BACKGROUND

PMID: 22084369 (View on PubMed)

Other Identifiers

ALK-OBS

Identifier Type: -

Identifier Source: org_study_id