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

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

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

Sponsors & Collaborators

• Goethe University

  lead OTHER

Principal Investigators

• Nicola Gökbuget, Dr. med. · University Hospital of Frankfurt (Main)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Germany

Study Locations