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

September 25, 2023 updated by: The Lymphoma Academic Research Organisation

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens - Hopital Sud
      • Clermont-Ferrand, France
        • CHU d'Estaing
      • Creteil, France
        • APHP - Hopital Henri Mondor
      • Grenoble, France
        • CHU Grenoble
      • Lille, France
        • CHRU de Lille - Hopital Claude Huriez
      • Marseille, France
        • Institut Paoli Calmette
      • Paris, France
        • APHP - Hôpital Necker
      • Paris Cedex 10, France
        • APHP - Hôpital Saint Louis
      • Pessac, France
        • CHU Bordeaux - Centre Francois Magendie
      • Pierre Bénite, France
        • Centre Hospitalier Lyon Sud
      • Rennes, France
        • CHU de Rennes - Hopital de Pontchaillou
      • Rouen, France
        • Centre Henri Becquerel
      • Strasbourg, France
        • CHRU de Strasbourg
      • Toulouse, France
        • Institut Universitaire du Cancer de Toulouse - Oncopole
      • Vandoeuvre les Nancy, France
        • Chu Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Anaplastic large-cell lymphoma ALK+

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
Time Frame: 1 month
1 month
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
Time Frame: 2 years
2 years
Prognostic value of biological parameters on the incidence of relapse
Time Frame: Day 0
Day 0
Prognostic value of biological parameters on the incidence of relapse
Time Frame: 1 month
1 month
Prognostic value of biological parameters on the incidence relapse
Time Frame: 2 years
2 years
Prognostic value of biological parameters on the Progression Free Survival (PFS)
Time Frame: Day 0
Day 0
Prognostic value of biological parameters on the Progression Free Survival (PFS)
Time Frame: 1 month
1 month
Prognostic value of biological parameters on the Progression Free Survival (PFS)
Time Frame: 2 years
2 years
Prognostic value of biological parameters on the Overall Survival (OS)
Time Frame: Day 0
Day 0
Prognostic value of biological parameters on the Overall Survival (OS)
Time Frame: 1 month
1 month
Prognostic value of biological parameters on the Overall Survival (OS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Collaborators

Pfizer
Takeda
Hôpital Necker-Enfants Malades
Fondation ARC

Investigators

  • Principal Investigator: David SIBON, MD, Hôpital Necker-Enfants Malades

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2018

Primary Completion (Actual)

June 16, 2023

Study Completion (Actual)

June 16, 2023

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK-OBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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