Last updated: 11/04/2018 08:15:28

HuMax-CD20 in Chronic Lymphocytic Leukemia

GSK study ID
Hx-CD20-402
Clinicaltrials.gov ID
NCT00093314
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Withdrawn
Withdrawn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-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
Trial description: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
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:
2007-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Chronic Lymphocytic Leukemia
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2004 to January 2007
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Chronic Lymphocytic Leukemia
  • Circulating lymphocytes above a specific level
  • Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
  • Previous stem cell transplantation.
Inclusion and exclusion criteria
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.

Trial location(s)

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

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
Actual primary completion date
2007-31-01
Actual study completion date
2007-31-01

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
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