Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma - Full Text View

Sponsor:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00092274

Purpose

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

Condition	Intervention	Phase
Lymphoma, Follicular	Drug: HuMax-CD20	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Ofatumumab

U.S. FDA Resources

Further study details as provided by Genmab:

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Previous treatment with rituximab resulting in less than partial response
Previous radioimmunotherapy
Previous stem cell transplantation
Received the following treatments within 4 weeks prior to entering this study:
1. Anti-cancer therapy
2. Glucocorticosteroids unless less than 10 mg prednisolone/day
3. Radiotherapy
Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
HIV positivity
Hepatitis B or hepatitis C
Uncontrolled or chronic bacterial, fungal or viral infection
Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
WHO performance status of 3 or 4
If you are participating in another trial with a different new drug 4 weeks before you enter this trial
Current participation in any other clinical study
Pregnant or breast-feeding women
Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092274

Locations

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Genmab

More Information

No publications provided by Genmab

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier:	NCT00092274 History of Changes
Other Study ID Numbers:	Hx-CD20-001
Study First Received:	September 22, 2004
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genmab:

Follicular Lymphoma
Non Hodgkin´s Lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 21, 2012