Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Neufeld, Ellis J, MD, PhD
Study ID
NCT01713738
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Idiopathic Thrombocytopenic Purpura (ITP)
  • Immune Thrombocytopenic Purpura (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    infusion of 4 weekly doses of 375 mg/m2 rituximab

Study Details

The purpose of the study is to evaluate the safety and efficacy of rituximab in children ages 18 months to 18 years, who have severe, chronic ITP. Eligible patients with either primary or secondary ITP are treated with rituximab once a week for 4 doses, and then followed for up to one year. Response is defined as having a platelet count greater than or equal to 50,000/mL on four consecutive weekly measures beginning anytime in weeks 9 - 12.

Key Dates

Start date
May 31, 2003
Status verified
Nov 2012
Primary completion
Dec 31, 2005
Completion
Dec 31, 2005

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab

Primary Outcome Measure

platelet levels [ Time Frame: 9 - 12 weeks after 1st dose of rituximab ]

Locations (9)

FacilityCityStateZIPSite coordinators
UCLA, Mattel Children's HospitalLos AngelesCalifornia90095-
Stanford University School of MedicinePalo AltoCalifornia94305-
University of California, San FranciscoSan FranciscoCalifornia94143-
Emory University School of MedicineAtlantaGeorgia30322-
Children's Hospital BostonBostonMassachusetts02115-
Van Eslander Cancer Center, St. John HospitalDetroitMichigan48236-
Weill Medical College at Cornell UniversityNew YorkNew York10021-
Southwestern Medical Center at DallasDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
UCLA, Mattel Children's Hospital· Los Angeles, CAStanford University School of Medicine· Palo Alto, CAUniversity of California, San Francisco· San Francisco, CAEmory University School of Medicine· Atlanta, GAChildren's Hospital Boston· Boston, MAVan Eslander Cancer Center, St. John Hospital· Detroit, MI

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