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HuMax-CD20 in Chronic Lymphocytic Leukemia

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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00093314
Enrollment
0
Registered
2004-10-08
Start date
2004-10-31
Completion date
2007-01-31
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, B-cell Lymphoma

Brief summary

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

Interventions

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026