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

NCT02067143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-09-08

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Renato Bassan, Pr. · Azienda ULSS 12 Veneziana

  • Roberto Foà, Pr. · Policlinico Umberto I, Hematology Department.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-20
Primary Completion
2016-10-07
Completion
2020-12-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067143 on ClinicalTrials.gov