A Phase 2 interventional study of Postremission consolidation based on MRD status in Acute Lymphoblastic Leukemia, sponsored by Northern Italy Leukemia Group. Completed at 15 sites in Italy. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-29.
Sponsored by Northern Italy Leukemia Group · Phase 2, Interventional, and Treatment
The study aims to optimize the concept of risk-oriented postremission consolidation therapy, by offering (i) standard consolidation-maintenance to patients at lowest risk of relapse as defined by MRD(Minimal Residual Disease) negative status, and (ii) allogeneic stem cell transplantation (related/unrelated donor available) or multicycle high-dose therapy with autologous blood stem cell transplant (no donor) to patients at highest risk of relapse as defined by MRD+ status.
The prognostic role of MRD evaluation in unselected patients will be evaluated.
Improved outcome of adult ALL through the application of:
Phase B therapy according to MRD results and ALL subset:
The illustrated strategy aims to optimize postremission consolidation therapy by offering standard treatment "only" to patients at lowest risk of relapse (MRD-), thereby reducing the risks of high dose treatments (expected TRM from allogeneic SCT 20-30%), while maintaining the latter approach in MRD+ cases and very HR subsets.
The prognostic role of MRD evaluation in unselected patients will be evaluated.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 280 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Northern Italy Leukemia Group is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)
Behavioral: Postremission consolidation based on MRD status
Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)
Also known as: MRD-guided therapy
Disease-free survival at 5 years
Time frame: 5 year from date of complete remission
Complete remission
Time frame: 4 or 8 weeks from date of therapy start
Overall survival
Time frame: 5 years from date of diagnosis
Cumulative incidence of relpase
Time frame: 5 years from date of complete remission
Remissional deaths
Time frame: 4 weeks from date of therapy start
Nonlethal toxicity
Time frame: 5 years from date of therapy start
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Northern Italy Leukemia Group