Clinical trial · Interventional
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
NCT00093314CI-TRIAL-00017595withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Acquired asset
Summary
Brief summary (as posted)
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HuMax-CD20 | Drug | Ofatumumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDStruemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28. PMID 24443277
- DERIVEDCoiffier B, Losic N, Ronn BB, Lepretre S, Pedersen LM, Gadeberg O, Frederiksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Robak T, Petersen J. Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study. Br J Haematol. 2010 Jul;150(1):58-71. doi: 10.1111/j.1365-2141.2010.08193.x. Epub 2010 Apr 16. PMID 20408846
- DERIVEDCoiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. 2008 Feb 1;111(3):1094-100. doi: 10.1182/blood-2007-09-111781. Epub 2007 Nov 14. PMID 18003886