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Completed

NCT Number: NCT02191930

Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma

The purpose of this trial is to determine

1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy 2. Progression-free survival (PFS) 3 years after registration

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(B-CAP):

  • classical Hodgkin Lymphoma
  • Age 60 years or older
  • ECOG performance status ≤ 2 or ≤ 3 if due to HL
  • CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
  • Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
  • written informed consent

Exclusion criteria

(B-CAP):

  • Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
  • Prior chemotherapy or radiation for HL except prephase
  • Peripheral neuropathy greater than CTC Grade 1

Inclusion criteria

(BV only):

  • classical Hodgkin Lymphoma
  • Age 60 years or older
  • stage IA to IVB
  • CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
  • Patients not eligible to curative poly-chemotherapy at the investigators judgment
  • written informed consent

Exclusion criteria

(BV only):

  • Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
  • Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
  • Peripheral neuropathy greater than CTC Grade 1

Treatment and study plan

B-CAP

Drug

Other names: Brentuximab Vedotin, Cyclophosphamide, Doxorubicine, Predniso(lo)ne

Brentuximab Vedotin

Drug

Primary outcomes

  1. Objective response rate

    Time frame: after 6 cycles of therapy (at least 18 weeks after start of treatment)

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -

Acronym: BVB

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2014
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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