Trials / Unknown
UnknownNCT01339988
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
Treatment Plan for Hematologic Malignancies Using Intravenous Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide to Examine Results, Success and Side Effects of Treatment With Chemotherapy Only, as a Preparative Therapy for Patients With Cord Blood Transplants
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Tel-Aviv Sourasky Medical Center · Other Government
- Sex
- Male
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Long-term follow-up studies have demonstrated significant late toxicities of total body irradiation (TBI), which are most marked in children radiated at a young age. Growth failure, decline in cognitive function, and endocrine abnormalities have all been described. Good outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte globulin (ATG) to reduce the late toxicities of therapy that includes TBI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Busulfan/Cyclophosphamide | Conditioning regimen: Cyclophosphamide 50mg/kg/day for 4 days + Busulfan 0.8-1.0mg/kg/day for 4 days. |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2014-06-01
- Completion
- 2019-06-01
- First posted
- 2011-04-21
- Last updated
- 2011-04-21
Source: ClinicalTrials.gov record NCT01339988. Inclusion in this directory is not an endorsement.