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

December 8, 2025 updated by: Nicola Goekbuget, Goethe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1023

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany, 60590
        • University Hospital of Frankfurt (Main)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
  • Lymphoblastic lymphoma (B or T-lineage)
  • Age 18-55 yrs
  • Written informed consent
  • Adequate contraception as specified per protocol

Exclusion Criteria:

  • Severe comorbidity or leukemia associated complications
  • Late relapse of pediatric ALL or ALL as second malignancy
  • Cytostatic pre-treatment
  • Pregnancy or breast feeding
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Participation in other clinical trials interfering with the study therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stratification I - Standard Risk (SR)/ High Risk (HR)
Induction and consolidation I therapy for standard and high risk patients, PH/BCR-ABL-negative Chemotherapy, immunotherapy, intrathecal prophylaxis, CNS irradiation according to randomisation I Drugs: Rituximab, Vincristine, Daunorubicin, Dexamethasone, Cyclophosphamide, Cytarabine, Mercaptopurine, PEG-Asparaginase, Methotrexate, Vindesine, VP16
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Rituximab
Drug: Dexamethasone
Drug: Cytarabine
Drug: Mercaptopurine
Drug: Vindesine
Drug: VP16
Drug: PEG-Asparaginase
Drug: Daunorubicin (DNR)
Other: Stratification I - Philadelphia (PH)+
Induction and consolidation I therapy for PH+ patients Chemotherapy, immunotherapy, intrathecal prophylaxis Drugs: Rituximab, Vincristine, Imatinib, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, VP16
Drug: Methotrexate
Drug: Vincristine
Drug: Rituximab
Drug: Dexamethasone
Drug: Imatinib
Drug: Cytarabine
Drug: Vindesine
Drug: VP16
Drug: PEG-Asparaginase
Active Comparator: Rand I - B-Lin + CNS Rad + i.th. MTX
Chemotherapy according to Stratification I SR/HR CNS prophylaxis: CNS irradiation 24 Gy, intrathecal Methotrexate
Drug: Methotrexate
Procedure: Cranial irradiation
Experimental: Rand I - B-Lin + i.th. MTX
Chemotherapy according to Stratification I SR/HR CNS prophylaxis: intrathecal Methotrexate
Drug: Methotrexate
Other: Stratification II - SR + MRD-neg
Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine, Dexamethasone
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Dexamethasone
Drug: Nelarabine
Drug: Prednisolone
Drug: Cytarabine
Drug: Vindesine
Drug: Adriamycin
Drug: PEG-Asparaginase
Other: Stratification II - HR + MRD-neg
Chemotherapy or stem cell transplantation according to randomisation II
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Nelarabine
Drug: Prednisolone
Drug: Cytarabine
Drug: Vindesine
Drug: Adriamycin
Procedure: Stem cell transplantation
Drug: PEG-Asparaginase
Other: Stratification II - SR/HR/PH+ + MRD-pos
Chemotherapy or targeted therapy, followed by stem cell transplantation Drugs: Fludarabine, Idarubicin, Cytarabine, Nelarabine
Drug: Nelarabine
Drug: Fludarabine
Drug: Cytarabine
Drug: Idarubicin
Active Comparator: Randomisation II - HR + MRD-neg-SCT
Stem cell transplantation
Procedure: Stem cell transplantation
Experimental: Randomisation II - HR + MRD-neg-SR-chemo
Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Dexamethasone
Drug: Nelarabine
Drug: Prednisolone
Drug: Cytarabine
Drug: Vindesine
Drug: Adriamycin
Drug: PEG-Asparaginase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: 3.5 years
3.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time until consolidation treatment I
Time Frame: approximately 70 days
approximately 70 days
Disease free survival
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 10 years
up to 10 years
Hematological remission rate
Time Frame: after induction, approximately 6-8 weeks from diagnosis
after induction, approximately 6-8 weeks from diagnosis
Molecular remission rate
Time Frame: after induction and consolidation, approximately 6-8 weeks from diagnosis
after induction and consolidation, approximately 6-8 weeks from diagnosis
Results of the positron emission tomography (PET) based remission evaluation
Time Frame: after consolidation, approximately 8-10 weeks
after consolidation, approximately 8-10 weeks
Remission duration
Time Frame: up to 10 years
up to 10 years
Relapse rate
Time Frame: up to 10 years
up to 10 years
Relapse location
Time Frame: at timepoint of relapse (up to 10 years)
at timepoint of relapse (up to 10 years)
Early death
Time Frame: during induction, approximately 6-8 weeks from diagnosis
during induction, approximately 6-8 weeks from diagnosis
Death in clinical remission (CR)
Time Frame: during treatment, up to approximately 2.5 years from diagnosis
during treatment, up to approximately 2.5 years from diagnosis
Comorbidities according to Charlson Score
Time Frame: up to 2.5 years
up to 2.5 years
Quality of life assessed by QLQ-C30
Time Frame: up to 2.5 years
up to 2.5 years
Eastern Cooperative Oncology Group (ECOG) under therapy
Time Frame: up to 2.5 years
up to 2.5 years
Toxicity assessed by CTCAE v4.03
Time Frame: up to 2.5 years
up to 2.5 years
Results of the Dementia Detection (DemTect) test
Time Frame: up to 2.5 years
up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

  • Principal Investigator: Nicola Gökbuget, Dr. med., University Hospital of Frankfurt (Main)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimated)

August 26, 2016

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL08_2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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