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

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ClinicalTrials.gov Identifier: NCT03603847
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Hôpital Necker-Enfants Malades
Fondation ARC
Pfizer
Takeda
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

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
Anaplastic Large Cell Lymphoma, ALK-Positive

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).


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023





Primary Outcome Measures :
  1. Prognostic value of biological parameters on the complete metabolic response rate (MCR) [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Prognostic value of biological parameters on the complete metabolic response rate (MCR) [ Time Frame: 1 month ]
  2. Prognostic value of biological parameters on the complete metabolic response rate (MCR) [ Time Frame: 2 years ]
  3. Prognostic value of biological parameters on the incidence of relapse [ Time Frame: Day 0 ]
  4. Prognostic value of biological parameters on the incidence of relapse [ Time Frame: 1 month ]
  5. Prognostic value of biological parameters on the incidence relapse [ Time Frame: 2 years ]
  6. Prognostic value of biological parameters on the Progression Free Survival (PFS) [ Time Frame: Day 0 ]
  7. Prognostic value of biological parameters on the Progression Free Survival (PFS) [ Time Frame: 1 month ]
  8. Prognostic value of biological parameters on the Progression Free Survival (PFS) [ Time Frame: 2 years ]
  9. Prognostic value of biological parameters on the Overall Survival (OS) [ Time Frame: Day 0 ]
  10. Prognostic value of biological parameters on the Overall Survival (OS) [ Time Frame: 1 month ]
  11. Prognostic value of biological parameters on the Overall Survival (OS) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, constitutional DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Anaplastic large-cell lymphoma ALK+
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603847


Contacts
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Contact: Fanny CHERBLANC, PhD +33 (0)4 27 01 27 17 fanny.cherblanc@lysarc.org

Locations
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France
CHU Amiens - Hôpital Sud Recruiting
Amiens, France
Contact: Ghandi DAMAJ, MD         
CHU d'Estaing Recruiting
Clermont-Ferrand, France
Contact: Sebastien BAILLY, MD         
APHP - Hopital Henri Mondor Recruiting
Creteil, France
Contact: Jehan DUPUIS, MD         
CHU Grenoble Recruiting
Grenoble, France
Contact: Remy GRESSIN, MD         
CHRU de Lille - Hôpital Claude Huriez Recruiting
Lille, France
Contact: Franck MORSCHHAUSER, Pr         
Institut Paoli Calmette Recruiting
Marseille, France
Contact: Reda BOUABDALLAH         
APHP - Hôpital Saint Louis Recruiting
Paris Cedex 10, France
Contact: Catherine Thieblemont, MD         
APHP - Hôpital Necker Recruiting
Paris, France
Contact: David Sibon, MD         
CHU Bordeaux - Centre François Magendie Recruiting
Pessac, France
Contact: Kamal BOUABDALLAH         
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France
Contact: Emmanuel BACHY, MD         
CHU de Rennes - Hôpital de Pontchaillou Recruiting
Rennes, France
Contact: Roch HOUOT, MD         
Centre Henri Becquerel Recruiting
Rouen, France
Contact: Hervé TILLY, MD         
CHRU de Strasbourg Recruiting
Strasbourg, France
Contact: Luc-Matthieu Fornecker, MD         
Institut Universitaire du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France
Contact: Loïc YSEBAERT, MD         
CHU Brabois Recruiting
Vandoeuvre les Nancy, France
Contact: Pierre FEUGIER         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Hôpital Necker-Enfants Malades
Fondation ARC
Pfizer
Takeda
Investigators
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Principal Investigator: David SIBON, MD Hôpital Necker-Enfants Malades

Publications:
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT03603847     History of Changes
Other Study ID Numbers: ALK-OBS
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin