Ofatumumab (Humax-CD20) With CHOP in FL Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 29, 2007

Last Updated Date

January 19, 2009

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Objective Response Rate as measured from start of treatment until 3 months after last infusion assessed according to the standardized response criteria for non-Hodgkin's Lymphomas (1;2) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00494780 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Duration of response, Time to next FL- therapy, Reduction in tumor size, Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Ofatumumab (Humax-CD20) With CHOP in FL Patients

Official Title ^†

An Open-Labeled, Randomized, Two-Dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma.

Brief Summary

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP in previously untreated patients with Follicular Lymphoma

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Follicular Lymphoma

Intervention ^†

Drug: Ofatumumab

Study Arms / Comparison Groups

Active Comparator: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
Active Comparator: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

November 2013

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patient with Follicular Lymphoma
Confirmed diagnosis of Follicular lymphoma
18 years or above
Verbal and written information about the study

Exclusion Criteria:

No previous treatment for Follicular Lymphoma
Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
Several diseases such as malignancies etc.
Screening laboratory values
Current participation in any other interventional clinical study
Breast feeding women or pregnant women
Women of childbearing potential not willing to use adequate contraception

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Czech Republic, Denmark, Germany, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00494780

Responsible Party

Genmab A/S, Genmab A/S

Secondary IDs ^††

Study Sponsor ^†

Genmab

Collaborators ^††

GlaxoSmithKline

Investigators ^†

Principal Investigator:

Myron Czuczman, Ass. Prof. M.D.

Roswell Park Cancer Institute

Information Provided By

Genmab

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.