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A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia

NCT01814488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-03-10

No results posted yet for this study

Summary

The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation as a potential curative procedure in a population of patients with chemoresistant acute leukemias.

Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation.

Conditions

Interventions

PROCEDURE

allogeneic transplant

Allogenic transplant using either a Marrow Unrelated Donor or a Cord Blood unit or a family Haploidentical donor. The conditioning regimen in standard use is: Thiotepa (Tepadina) i.v. 5 mg/kg/daily (total dose 10 mg/kg) day -7 and -6; Busulfan (Busilvex) i.v. 3,2 mg/kg/day (total dose 9,6 mg/kg) as a single daily dose day -5, -4, -3; Fludarabine i.v. 50 mg/m2 (total dose150 mg/m2) day -5, -4, -3. Primary antifungal prophylaxis is Micafungin 50 mg/die i.v. (1 mg/kg if \<40 kg) day 0 to engraftment. After engraftment continue antifungal prophylaxis according to local practice.

Sponsors & Collaborators

  • Gruppo Italiano Trapianto di Midollo Osseo

    lead OTHER

Principal Investigators

  • Fabio Ciceri, MD · Ospedale San Raffaele

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814488 on ClinicalTrials.gov