NCT00093314

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 21, 2015

Status Verified

January 1, 2007

Enrollment Period

2.3 years

First QC Date

October 6, 2004

Last Update Submit

April 20, 2015

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaB-cell Lymphoma

Interventions

HuMax-CD20DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Lymphocytic Leukemia
  • Circulating lymphocytes above a specific level
  • Circulating lymphocytes showing certain markers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa, Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

  • Struemper 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: 24443277DERIVED

  • Coiffier 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: 20408846DERIVED

  • Coiffier 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: 18003886DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphoma
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

October 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 21, 2015

Record last verified: 2007-01

Locations

US(1)