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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00598624
Other study ID # 2005-005182-11
Secondary ID
Status Unknown status
Phase Phase 2
First received January 10, 2008
Last updated August 10, 2009
Start date September 2005
Est. completion date December 2010

Study information

Verified date August 2009
Source IRCCS San Raffaele
Contact Luciano LC Callegaro, Monitor
Phone +390226433903
Email callegaro.luciano@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Intervention

Drug:
Treosulfan IV
Treosulfan i.v.: 14 g/m²/d from day -6 to day -4

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Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Evaluation of engraftment 28 days
Primary Safety: Evaluation of the incidence of CTC grade 3 and 4 adverse events between day -6 and day +28
Secondary Efficacy: Evaluation of disease free survival (DFS) 1 year
Secondary Efficacy: Evaluation of overall survival (OS) 1 year
Secondary Efficacy: Evaluation of relapse incidence (RI) 1 year
Secondary Efficacy: Documentation of donor chimerism on day +28, +56 and +100
Secondary Safety: Evaluation of incidence of non-relapse mortality (NRM) on day +28 and day +100
Secondary Safety: cumulative incidence of NRM 1 year
Secondary Safety: Evaluation of cumulative incidence and severity of acute and chronic graft vs. host disease (GvHD) 1 year
Secondary Safety: EBV reactivation 1 year
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