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Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL

NCT01358747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-02-09

No results posted yet for this study

Summary

All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.

Conditions

  • Hodgkin's Lymphoma

Interventions

DRUG

BEACOPPesc

DRUG

BEACOPPesc - ABVD - PET2

Sponsors & Collaborators

  • The Lymphoma Study Association

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Principal Investigators

  • René-Olivier CASASNOVAS, MD · CHU Dijon

Study Design

Allocation
RANDOMIZED
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358747 on ClinicalTrials.gov