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

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Lymphoma, Follicular

Treatments: Drug: HuMax-CD20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092274

Hx-CD20-001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)