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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00092274
Other study ID # Hx-CD20-001
Secondary ID
Status Withdrawn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Status Withdrawn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


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, 

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