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

Lymphoma, Follicular Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00092274
• Other study ID #: Hx-CD20-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 22, 2004
• Last updated: April 20, 2015
• Start date: September 2004
• Est. completion date: January 2005

Study information

• Verified date: January 2005
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Relapsed or refractory follicular lymphoma grade I-II

• Tumor verified to be CD20 positive

• CT scan showing demarcated lesions

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• HuMax-CD20

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States,