NCT02881086

Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,023 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A phase IV study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease (MRD) based individualised and intensified therapy. Study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two randomisations will focus on the role of central nervous system (CNS) irradiation in combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL and the role of SCT in high-risk patients with molecular complete remission. Finally a new, dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL positive ALL.

Conditions

• Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab
DRUG	Nelarabine
DRUG	PEG-Asparaginase
PROCEDURE	Cranial irradiation
DRUG	Imatinib
DRUG	Idarubicin
DRUG	Dexamethasone
DRUG	Cyclophosphamide
DRUG	Fludarabine
DRUG	Vincristine
DRUG	Mercaptopurine
DRUG	VP16
DRUG	Daunorubicin (DNR)
DRUG	Methotrexate
PROCEDURE	Stem cell transplantation
DRUG	Cytarabine
DRUG	Vindesine
DRUG	Adriamycin
DRUG	Prednisolone

Timeline

• Start date: 2016-08-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2016-08-26
• Last updated: 2025-12-16

Locations

1 site across 1 country: Germany