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HD21 for Advanced Stages

NCT02661503 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-05-13

No results posted yet for this study

Summary

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).

If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Conditions

  • Classical Hodgkin Lymphoma

Interventions

DRUG

Bleomycin

DRUG

Etoposide

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Vincristine

DRUG

Procarbazine

DRUG

Prednisone

DRUG

Brentuximab Vedotin

DRUG

Dacarbazine

DRUG

Dexamethasone

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Peter Borchmann, Prof. · University of Cologne, I. Dept. of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-12-31
Completion
2025-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02661503 on ClinicalTrials.gov