Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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).
Study Design
Outcome Measures
Primary Outcome Measures
- Prognostic value of biological parameters on the complete metabolic response rate (MCR) [Day 0]
Secondary Outcome Measures
- 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]
- Prognostic value of biological parameters on the Progression Free Survival (PFS) [Day 0]
- Prognostic value of biological parameters on the Progression Free Survival (PFS) [1 month]
- Prognostic value of biological parameters on the Progression Free Survival (PFS) [2 years]
- Prognostic value of biological parameters on the Overall Survival (OS) [Day 0]
- Prognostic value of biological parameters on the Overall Survival (OS) [1 month]
- Prognostic value of biological parameters on the Overall Survival (OS) [2 years]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens - Hôpital Sud | Amiens | France | ||
| 2 | CHU d'Estaing | Clermont-Ferrand | France | ||
| 3 | APHP - Hopital Henri Mondor | Creteil | France | ||
| 4 | CHU Grenoble | Grenoble | France | ||
| 5 | CHRU de Lille - Hôpital Claude Huriez | Lille | France | ||
| 6 | Institut Paoli Calmette | Marseille | France | ||
| 7 | APHP - Hôpital Saint Louis | Paris Cedex 10 | France | ||
| 8 | APHP - Hôpital Necker | Paris | France | ||
| 9 | CHU Bordeaux - Centre François Magendie | Pessac | France | ||
| 10 | Centre Hospitalier Lyon Sud | Pierre Bénite | France | ||
| 11 | CHU de Rennes - Hôpital de Pontchaillou | Rennes | France | ||
| 12 | Centre Henri Becquerel | Rouen | France | ||
| 13 | CHRU de Strasbourg | Strasbourg | France | ||
| 14 | Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | France | ||
| 15 | CHU Brabois | Vandoeuvre les Nancy | France |
Sponsors and Collaborators
- The Lymphoma Academic Research Organisation
- Hôpital Necker-Enfants Malades
- Fondation ARC
- Pfizer
- Takeda
Investigators
- Principal Investigator: David SIBON, MD, Hôpital Necker-Enfants Malades
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugières 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.
- Sibon D, Fournier M, Brière 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.
- ALK-OBS