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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Follicular

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

Hx-CD20-001

NCT ID:

NCT00092274

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma, Follicular
  • Follicular Lymphoma
  • Non Hodgkin´s Lymphoma
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242