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Trial record 68 of 107 for:    PHENYTOIN

Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00040469
Recruitment Status : Terminated
First Posted : June 28, 2002
Last Update Posted : April 11, 2007
Sponsor:
Collaborators:
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:
Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE June 26, 2002
First Posted Date  ICMJE June 28, 2002
Last Update Posted Date April 11, 2007
Study Start Date  ICMJE August 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00040469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies
Official Title  ICMJE Allogeneic Bone Marrow Transplant From HLA Identical Related Donors for Patients With High Risk Hemoglobinopathies: Hemoglobin SS, Hemoglobin SC, Hemoglobin SB0/+ Thalassemia, or Homozygous B0/+ Thalassemia or Severe Variants of B0/+ Thalassemia
Brief Summary The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
Detailed Description

To do the bone marrow transplant, we must first kill the cells in the bone marrow that make the abnormal red blood cells that are found in patients with severe thalassemia or sickle cell disease.

We will do this by using three drugs: busulfan, cyclophosphamide, and CAMPATH-1H. CAMPATH-IH is an investigational drug. CAMPATH-1H is used to prevent participants from rejecting or refusing to let the donor blood cells grow in the body. After the drug treatment, participants will be given bone marrow from a brother or sister who has healthy bone marrow that matches.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Anemia
  • Hemoglobinopathy
  • Thalassemia
Intervention  ICMJE
  • Drug: Campath -1H
  • Drug: Dilantin
  • Drug: Busulfan
  • Drug: Cyclophosphamide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
15
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion:

  • Patients with homozygous B0/+ thalassemia or severe variants of B0/+ thalassemia with an HLA genotypically identical donor.
  • Patients with an HLA genotype identical donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb 0/+ and at least one of the following:

Previous central nervous system vaso-occlusive episode with or without residual neurologic findings; Frequent painful vaso-occlusive episodes which significantly interfere with normal life activities and which necessitate chronic transfusion therapy; Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.

  • Severe anemia which prevents acceptable quality of life and necessitates chronic transfusion therapy.
  • The patient must have an HLA genotype identical donor.
  • Between the ages of birth and 65 years.
  • Women of childbearing potential must have a negative pregnancy test.

Exclusion:

  • Biopsy proven chronic active hepatitis or fibrosis with portal bridging.
  • SCD chronic lung disease >/= stage 3.
  • Severe renal dysfunction defined as creatinine clearance <40 ml/min/1.73 M2
  • Severe cardiac dysfunction defined as shortening fraction <25%.
  • HIV infection.
  • Severe but unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate bone marrow transplant (BMT).
  • Inadequate intellectual capacity to understand the nature and risk inherent in the BMT process and give informed consent (in the case of minors, this criteria must be fulfilled by the legal guardian).
  • Pregnant, lactating or unwilling to use appropriate birth control.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00040469
Other Study ID Numbers  ICMJE H6847
Scallo2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE
  • The Methodist Hospital System
  • Texas Children's Hospital
  • Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators  ICMJE
Study Chair: Malcolm K. Brenner, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP