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HD21

AcronymISRCTNEudraCTClinicaltrials.govDRKS
UNI-Koeln-17622014-005130-55NCT02661503

Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD

Status: Active

Purpose / Objectives

Primary Outcome

  • Progression-free survival (PFS)
  • Treatment-related morbidity (TRMorbidity)

Secondary Outcomes

  • Tumor response (CR/CRr rate)
  • Overall survival (OS)
  • Infertility rate at 1 year
  • Second malignancies
  • Quality of life (QoL)
  • Frequency of adverse events
  • Therapy adherenc

Diagnosis

hodgkin lymphoma

Patient attributes

Stage

advanced

Age

18-60

Inclusion criteria

  • 1. Histologically proven classical Hodgkin lymphoma
  • 2. Stage:
    • 2.1 CS (PS) IIB with one or both of the following risk factors:
      • a) Large mediastinal mass (≥ 1/3 of the maximum transverse thoracic diameter)
      • b) Extranodal disease (see definition in section 13.4)
    • 2.2 CS (PS) III; IV
  • 3. Patient has had no previous treatment for HL
  • 4. Age at entry: 18 – 60 years
  • 5. Patient has given their written informed consent to participate in the trial
  • 6. Patient agrees to their personal data and tissue material being used for the study, with due regard for data protection
  • [...]

Exclusion criteria

  • Incomplete diagnosis of the disease stage
  • prior or concurrent disease that prevents treatment according to protocol, in particular the following contraindications:
    • Chronic obstructive pulmonary disease with global respiratory insufficiency
    • Status post myocardial infarction, symptomatic coronary heart disease, permanent arrhythmias > grade 2, status post thromboembolic events (deep vein thrombosis, pulmonary embolism, symptomatic cerebrovascular event), left ventricular ejection fraction < 50% within the last 6 months before start of chemotherapy
    • Exception: chronic stable atrial fibrillation under anticoagulation therapy is NOT an exclusion criterion
    • Cardiac insufficiency NYHA III or IV
    • QTc interval > 480 msec
    • Serious arterial hypertonia despite adequate medication
    • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at time of first study drug dose
    • HIV infection
    • Chronic active or persistent (PCR positive) hepatitis B and/or C
    • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
  • Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or composite lymphoma
  • Chemotherapy or radiotherapy in medical history
  • Malignant disease within the last 5 years (Exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1
  • [...]

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Open Label

Intervention

6x escalated BEACOPP vs. 6x BrECADD

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Prof. Dr. med. Peter Borchmann

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Peter Borchmann

Deputy of Principal Investigator

  • Dr. Stefanie Kreissl

Subinvestigator

  • Dr. med. Paul Bröckelmann
  • Univ.-Prof. Dr. med. Andreas Engert
  • Dr. Stefanie Kreissl
  • Dr. med. Nadine Kutsch
  • Dr. med. Armin Tuchscherer
  • PD Dr. med. Thomas Zander
  • Carolin Groß-Ophoff-Müller
  • Johanna Prinz
  • Jesko Momotow
  • Dr. med. Sarah Gillessen
  • Dr. med. Ron Jachimowicz
  • Dr. med. Carmen Diana Herling

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