NCT01187303

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

August 19, 2010

Last Update Submit

October 30, 2015

Conditions

Relapsed NLPHL

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    12 months after end of treatment

Secondary Outcomes (3)

  • duration of response

    12 months after end of treatment

  • Progression free survival

    12 months after end of treatment

  • adverse events

    12 months after end of treatment

Interventions

OfatumumabDRUG

300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andreas Engert, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 24, 2010

Study Start

May 1, 2011

Primary Completion

November 1, 2013

Study Completion

September 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

DE(1)