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

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ClinicalTrials.gov Identifier: NCT02191930
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: B-CAP Drug: Brentuximab Vedotin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 -
Actual Study Start Date : September 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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:
  • Brentuximab Vedotin
  • Cyclophosphamide
  • Doxorubicine
  • 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



Primary Outcome Measures :
  1. Objective response rate [ Time Frame: after 6 cycles of therapy (at least 18 weeks after start of treatment) ]


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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191930


Contacts
Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany, 50924
Contact: Michael Fuchs       ghsg@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Peter Borchmann, Prof. University Hospital of Cologne

Additional Information:
Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT02191930     History of Changes
Other Study ID Numbers: B-CAP
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Doxorubicin
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors