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TREATMENT OF MINIMAL RESIDUAL DISEASE (MRD) IN ACUTE LEUKEMIA AFTER AN ALLOGENEIC STEM CELL TRANSPLANT - ND

TREATMENT OF MINIMAL RESIDUAL DISEASE (MRD) IN ACUTE LEUKEMIA AFTER AN ALLOGENEIC STEM CELL TRANSPLANT - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005864-28-IT
Enrollment
Unknown
Registered
2009-03-23
Start date
2008-05-30
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute leukemia and positive MRD post allogeneic hemopoietic stem cell transplant (HSCT) MedDRA version: 9.1 Level: LLT Classification code 10000830 Term: Acute leukaemia

Interventions

Trade Name: leukine Pharmaceutical Form: Solution for injection INN or Proposed INN: Sargramostim Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500-

Sponsors

FONDAZIONE RICERCA TRAPIANTO DI MIDOLLO OSSEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients with a negative MRD post-transplant

Design outcomes

Primary

MeasureTime frame
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)—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026