Trials / Unknown
UnknownNCT00598624
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Haematological Malignancies
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- Sponsor
- IRCCS San Raffaele · Academic / Other
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.
Conditions
- Leukemia
- Chronic Myeloid Leukemia
- Myelodysplastic Syndrome
- Diffuse Large Cell Lymphoma
- Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Multiple Myeloma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treosulfan IV | Treosulfan i.v.: 14 g/m²/d from day -6 to day -4 |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2009-12-01
- Completion
- 2010-12-01
- First posted
- 2008-01-22
- Last updated
- 2009-08-11
Locations
12 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00598624. Inclusion in this directory is not an endorsement.