Trials / Unknown
UnknownNCT00006056
Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic Disorders
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Fairview University Medical Center · Academic / Other
- Sex
- All
- Age
- 0 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Determine the efficacy of unrelated donor hematopoietic stem cell transplantation in the treatment of patients with life threatening hemophagocytic disorders. II. Determine the rate of disease free survival, incidence of graft failure, and incidence of graft versus host disease in these patients after undergoing this treatment regimen.
Detailed description
PROTOCOL OUTLINE: Patients receive oral busulfan twice a day on days -9 to -6; cyclophosphamide IV over 1 hour on days -5 to -2; etoposide IV over 4 hours on days -5 to -3; and anti-thymocyte globulin IV twice a day on days -2 and -1 and days 1 and 2. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Filgrastim (G-CSF) is administered subcutaneously beginning on day 1 and continuing until blood counts recover. Patients receive graft versus host disease prophylaxis with methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally once the patients resumes eating) every 12 hours (every 8 hours for pediatric patients) starting on or prior to day -3 and continuing up to 1 year. Patients are followed at days 28 and 100, at 6 months and 1 year, and then annually for 5 years.
Conditions
- Chediak-Higashi Syndrome
- Graft Versus Host Disease
- X-Linked Lymphoproliferative Syndrome
- Familial Erythrophagocytic Lymphohistiocytosis
- Hemophagocytic Lymphohistiocytosis
- Virus-Associated Hemophagocytic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | anti-thymocyte globulin | |
| DRUG | busulfan | |
| DRUG | cyclophosphamide | |
| DRUG | cyclosporine | |
| DRUG | etoposide | |
| DRUG | filgrastim | |
| DRUG | methotrexate | |
| PROCEDURE | allogeneic hematopoietic stem cell transplantation |
Timeline
- Start date
- 2000-03-01
- First posted
- 2000-07-06
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00006056. Inclusion in this directory is not an endorsement.