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

Primary Purpose

Hodgkin Lymphoma

Status
Active
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
B-CAP
Brentuximab Vedotin
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Dept. of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

B-CAP

Brentoximab Vedotin only

Arm Description

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

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

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Full Information

First Posted
July 11, 2014
Last Updated
August 5, 2022
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02191930
Brief Title
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
Acronym
B-CAP
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to determine 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 Progression-free survival (PFS) 3 years after registration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B-CAP
Arm Type
Experimental
Arm Description
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
Arm Title
Brentoximab Vedotin only
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
B-CAP
Other Intervention Name(s)
Brentuximab Vedotin, Cyclophosphamide, Doxorubicine, Predniso(lo)ne
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
after 6 cycles of therapy (at least 18 weeks after start of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.ghsg.org
Description
Homepage GHSG

Learn more about this trial

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

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