NCT02067143

MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate

National Treatment Program of Philadelphia Chromosome-negative Adult Acute Lymphoblastic Leukemia With Pegylated Asparaginase Added to a Lineage-Targeted Risk- and Minimal Residual Disease-Oriented Strategy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in different centres and will study adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the achievement of an early negative minimal residual disease (MRD) status. The MRD study supports a risk/MRD-oriented final consolidation phase.

Detailed description

The aim of this clinical study in adult ALL is to improve , by risk category, the overall disease-free survival in relation to the achievement of an early MRD negative status and following induction/consolidation with Peg-ASP, lineage-targeted methotrexate infusions and other disease-specific therapeutic elements, with or without the application of allogeneic or autologous SCT depending on risk class and MRD study results. A survey of severe infections occurring along the entire chemotherapy and stem cell transplant program and until 2 years from the achievement of CR will be performed with the aim to increase the knowledge of these complications and to evaluate their impact on the antileukemic program and on the long term outcome of the underlying malignancy. The prospective survey of severe infections will be performed as an ancillary observational objective of the present study.

Conditions

• Untreated Philadelphia Positive Acute Lymphoblastic Leukemia
• De Novo
• Secondary
• Low-dose Corticosteroids Pretreatment

Interventions

Type	Name	Description
DRUG	Prephase PDN + CY
DRUG	Cycle 1 Induction
DRUG	Cycle 2 Induction / Early consolidation
DRUG	Cycle 3 Early consolidation
DRUG	Cycle 4 Consolidation
DRUG	Cycle 5 Consolidation
DRUG	Cycle 6 Consolidation
DRUG	Cycle 7 Consolidation
DRUG	Cycle 8 Reinduction
DRUG	Maintenance	If MRD negative MRD u/k SR
PROCEDURE	Allogeneic SCT or Autologous SCT	If MRD positive MRD u/k HR

Timeline

• Start date: 2014-05-20
• Primary completion: 2016-10-07
• Completion: 2020-12-07
• First posted: 2014-02-20
• Last updated: 2021-09-08

Locations

61 sites across 1 country: Italy