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

August 21, 2024 updated by: Prof. Dr. Peter Borchmann, University of Cologne

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

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

  • Germany
      • Cologne, Germany, 50924
        • 1st Dept. of Medicine, Cologne University Hospital

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

60 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B-CAP
Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
Drug: B-CAP
Other Names:
  • Cyclophosphamide
  • Doxorubicine
  • Brentuximab Vedotin
  • Predniso(lo)ne
Experimental: Brentoximab Vedotin only
Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days
Drug: Brentuximab Vedotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: after 6 cycles of therapy (at least 18 weeks after start of treatment)
after 6 cycles of therapy (at least 18 weeks after start of treatment)

Collaborators and Investigators

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

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Peter Borchmann, Prof., University Hospital of Cologne

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.

Helpful Links

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)

September 1, 2015

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimated)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-1707

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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