Know Cancer

or
forgot password

An Open-Labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

An Open-Labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Chronic Lymphocytic Leukemia

- Circulating lymphocytes above a specific level

- Circulating lymphocytes showing certain markers

Exclusion Criteria:

- Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment
in study.

- Previous stem cell transplantation.

- Received any of the following treatments within 4 weeks prior to entering this trial:
A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C)
Radiotherapy.

- HIV positivity.

- Hepatitis B or hepatitis C.

- Other cancerous diseases, except certain skin cancers and cervix cancer.

- Certain serious medical conditions, including kidney or liver disease, some
psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.

- Participation in another trial with a different new drug 4 weeks prior to enrollment
in study.

- Current participation in any other clinical study.

- Pregnant or breast-feeding women.

- Women of childbearing age who are unable or unwilling to use adequate contraception.

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-CD20-402

NCT ID:

NCT00093314

Start Date:

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • B-cell Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

University of Iowa, Hospitals and ClinicsIowa City, Iowa  52242