Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymp... | NCT01187303

Studies
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

NCT01187303

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Nov 2, 2015Estimated

Enrollment

28Actual

Phase

Phase 2

Conditions

Relapsed NLPHL

Interventions

Ofatumumab

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

Oct 2015

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

May 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Sep 2015Actual

First Submitted Date

Aug 19, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 24, 2010Estimated

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

Oct 30, 2015

Last Update Posted Date

Nov 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).

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

28Actual

Name	Type	Description	Arm Group Labels	Other Names
Ofatumumab	Drug	300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate		12 months after end of treatment

Secondary Outcomes

Measure	Description	Time Frame
duration of response		12 months after end of treatment
Progression free survival		12 months after end of treatment
adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

relapsed nodular lymphocyte predominant hodgkin lymphoma
age 18 - 75
review of diagnosis by experienced pathologist
no major organ dysfunction

Exclusion Criteria:

classical hodgkin lymphoma
CD20 antibody treatment within the last 6 months prior enrollment
chronic or current infectious disease requirering systemic antibiotics
other past or current malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Engert, MD	University of Cologne	Principal Investigator

Locations

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

Label	URL
Homepage of the German Hodgkin Study Group	View source

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C527517	ofatumumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided