TREATMENT OF MINIMAL RESIDUAL DISEASE (MRD) IN ACUTE LEUKEMIA AFTER AN ALLOGENEIC STEM CELL TRANSPLANT - ND
- Conditions
- Patients with acute leukemia and positive MRD post allogeneic hemopoietic stem cell transplant (HSCT)MedDRA version: 9.1Level: LLTClassification code 10000830Term: Acute leukaemia
- Registration Number
- EUCTR2007-005864-28-IT
- Lead Sponsor
- FONDAZIONE RICERCA TRAPIANTO DI MIDOLLO OSSEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with acute leukemia (AML and ALL), aged 18-70, Patients with a positive MRD post-transplant and they have no donor cells available at the time of MRD positivity. The stem cell source will be bone marrow or peripheral blood or cord blood according to availability .
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with a negative MRD post-transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TASK 1. confirm the low risk of relapse for MRD- and MRD+DLI+ patients. TASK 2. reduce the risk of relapse in patients who lack donor lymphocytes. TASK 3. test other markers of MRD.;Secondary Objective: none;Primary end point(s): Reduction of relapse of Leukemia on patients with Minimal Residual Disease (MRD)
- Secondary Outcome Measures
Name Time Method