Brentuximab Vedotin or B-CAP in the Treatment of Older Pa... | NCT02191930

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

NCT02191930

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Aug 23, 2024Actual

Enrollment

70Actual

Phase

Phase 2

Conditions

Hodgkin Lymphoma

Interventions

B-CAP
Brentuximab Vedotin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Mar 16, 2022Actual

Completion Date

Mar 16, 2022Actual

First Submitted Date

Jul 11, 2014

First Submission Date that Met QC Criteria

Jul 14, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 23, 2024Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B-CAP	Experimental	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
Brentoximab Vedotin only	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B-CAP	Drug		B-CAP	Brentuximab Vedotin Cyclophosphamide Doxorubicine Predniso(lo)ne

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter Borchmann, Prof.	University Hospital of Cologne	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
1st Dept. of Medicine, Cologne University Hospital		Cologne		50924	Germany

Label	URL
Homepage GHSG	View source

ID	Term
D006689	Hodgkin Disease

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D000079963	Brentuximab Vedotin
D003520	Cyclophosphamide
D004317	Doxorubicin

Ancestor Terms

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized

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