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

Anaplastic Large Cell Lymphoma, ALK-Positive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603847
• Other study ID #: ALK-OBS
• Status: Completed
• Start date: August 2, 2018
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: The Lymphoma Academic Research Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma, ALK-Positive
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic

Locations

Country	Name	City	State
France	CHU Amiens - Hôpital Sud	Amiens
France	CHU d'Estaing	Clermont-Ferrand
France	APHP - Hopital Henri Mondor	Creteil
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 Cedex 10
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	Vandoeuvre les Nancy

Sponsors (5)

Lead Sponsor	Collaborator
The Lymphoma Academic Research Organisation	Fondation ARC, Hôpital Necker-Enfants Malades, Pfizer, Takeda

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic value of biological parameters on the complete metabolic response rate (MCR)		Day 0
Secondary	Prognostic value of biological parameters on the complete metabolic response rate (MCR)		1 month
Secondary	Prognostic value of biological parameters on the complete metabolic response rate (MCR)		2 years
Secondary	Prognostic value of biological parameters on the incidence of relapse		Day 0
Secondary	Prognostic value of biological parameters on the incidence of relapse		1 month
Secondary	Prognostic value of biological parameters on the incidence relapse		2 years
Secondary	Prognostic value of biological parameters on the Progression Free Survival (PFS)		Day 0
Secondary	Prognostic value of biological parameters on the Progression Free Survival (PFS)		1 month
Secondary	Prognostic value of biological parameters on the Progression Free Survival (PFS)		2 years
Secondary	Prognostic value of biological parameters on the Overall Survival (OS)		Day 0
Secondary	Prognostic value of biological parameters on the Overall Survival (OS)		1 month
Secondary	Prognostic value of biological parameters on the Overall Survival (OS)		2 years