Last updated: 11/04/2018 08:15:20

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

GSK study ID
Hx-CD20-001
Clinicaltrials.gov ID
NCT00092274
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: HuMax-CD20
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2005-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lymphoma, Follicular
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2004 to November 2005
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Relapsed or refractory follicular lymphoma grade I-II
  • Tumor verified to be CD20 positive
  • Previous treatment with rituximab resulting in less than partial response
  • Previous radioimmunotherapy
Inclusion and exclusion criteria
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: a) Anti-cancer therapy b) Glucocorticosteroids unless less than 10 mg prednisolone/day c) 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 location(s)

Location
Status
Contact us
Contact us
Location
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Status
Study Complete
Contact us

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
Actual primary completion date
2005-31-01
Actual study completion date
2005-08-11

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website