GoldBamboo.com - Knowledge is strong medicine
  

Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura - Article


  Not Signed In - Sign In / Register






Idiopathic Thrombocytopenia Purpura

ITP


Clinical Trial: Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura

This study is not yet open for patient recruitment.
Verified by Weill Medical College of Cornell University November 2005

Sponsors and Collaborators: Weill Medical College of Cornell University
Genentech
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00251277

Purpose

The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with TTP. This includes evaluating the rate and type of treatment failure.
Condition Intervention Phase
Thrombotic Thombocytopenic Purpura
TTP
Hematology
 Drug: Rituximab
Phase I
Phase II

MedlinePlus related topics:  Bleeding Disorders;   Blood and Blood Disorders;   Vascular Diseases
Genetics Home Reference related topics:  thrombotic thrombocytopenic purpura

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Further study details as provided by Weill Medical College of Cornell University:

Expected Total Enrollment:  12

Study start: November 2005

Eligibility

Ages Eligible for Study:  17 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria

Patients must have TTP with platelet count < 100,000/mL and microangiopathic hemolytic anemia which is defined as presence of at 3-10 fragmented red blood cells (schistocytes) per high power filed on the peripheral blood smear.

Patients will be included in the trial based on the following criteria:

  • Either gender, age 17 or older
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
  • TTP not related to underlying cancer, treatment of cancer or transplantation
  • New onset TTP, or previously diagnosed TTP with an unmaintained remission for >12 months.
  • LDH >2X upper limit of normal
  • PT, PTT normal
  • Direct antiglobulin test (DAT) negative
  • Subject has provided written informed consent
  • Patients who have received up to 3 plasmapheresis.

Exclusion Criteria

Patients will be excluded from the trial based on the following criteria:

  • A diagnosis of AIDS. Patients with HIV infection with absolute CD4 counts >200/ul and no active, significant opportunistic infection are eligible
  • Patients with a known hepatitis C infection (HCV) and/or with hepatitis B
  • Patients receiving pheresis more than once a day
  • Recent (within 1 year) bone marrow or hematopoietic stem cell transplant
  • Patient is on calcineurin inhibitors, or is unable to come off them
  • Acute or chronic disseminated intravascular coagulation (DIC), defined by D-dimers >8mg/ml and fibrinogen < 100 mg (0.1g)/dl
  • A diagnosis of metastatic or non-metastatic malignancy other than basal cell carcinoma.
  • Malignant hypertension (systolic BP>200 mm Hg or a diastolic BP>130 mm Hg
  • Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment). Eligibility resumes 3 days after delivery
  • Patients with family history of or a previous diagnosis of congenital TTP
  • Patients with HUS
  • Patients with sepsis

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00251277

James B Bussel, M.D.      2120-746-3474    jbussel@med.cornell.edu

New York
      Weill Medical College of Cornell University/New York Presbyterian Hospital, New York,  New York,  10021,  United States
James B Bussel, M.D.  212-746-3474    jbussel@med.cornell.edu 

Study chairs or principal investigators

James B Bussel, M.D.,  Principal Investigator,  Weill Medical College of Cornell University   

More Information

Study ID Numbers:  U2785s
Last Updated:  December 8, 2005
Record first received:  November 7, 2005
ClinicalTrials.gov Identifier:  NCT00251277
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Idiopathic Thrombocytopenia Purpura.

October 6, 2008



Page Updated: September 6, 2005
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Massachusetts Law | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.