clinical trial to perform an allogeneic transplant in patients with acute leukemia active

Phase 1

• Conditions: Any active acute leukemia; MedDRA version: 14.1Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-004008-37-IT
• Lead Sponsor: GITMO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-29
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Diagnosis of Primary induction Failure (PIF) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Previous allogeneic transplant (autologous transplant is accepted)
Positive pregnancy test
Any active, uncontrolled infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified