Status:
COMPLETED
A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia
Lead Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Acute Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 l...
Detailed Description
The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation using either a Marrow Unrelated Donor (MUD) or a Cord Blood (CB) unit or a family Haploid...
Eligibility Criteria
Inclusion
- Diagnosis of Primary induction Failure or chemoresistant relapse in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) patients
- Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR)
- Age \>=18\<=70
- Unavailability of a HLA-matched related donor (MRD)
- Performance status: ECOG\<=3
- Written and signed informed consent
- Life expectancy not severely limited by concomitant illness.
Exclusion
- Previous allogeneic transplant (autologous transplant is accepted)
- Positive pregnancy test
- Any active, uncontrolled infection.
- \-
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01814488
Start Date
July 1 2013
End Date
June 30 2017
Last Update
March 10 2023
Active Locations (30)
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1
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, Italy
2
Policlinico
Bari, Italy
3
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
4
Ospedale San Orsola
Bologna, Italy