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OpenTrials
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NCT Number: NCT02881086

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Frankfurt (Main)

Frankfurt am Main, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

nelarabine

Drug

PEG-Asparaginase

Drug

Cranial irradiation

Procedure

Imatinib

Drug

Idarubicin

Drug

Dexamethasone

Drug

Cyclophosphamide

Drug

Fludarabine

Drug

Vincristine

Drug

mercaptopurine

Drug

VP16

Drug

Daunorubicin (DNR)

Drug

methotrexate

Drug

stem cell transplantation

Procedure

Cytarabine

Drug

Vindesine

Drug

Adriamycin

Drug

Prednisolone

Drug

Primary outcomes

  1. Event free survival

    Time frame: 3.5 years

Secondary outcomes

  1. Time until consolidation treatment I

    Time frame: approximately 70 days

  2. Disease free survival

    Time frame: 1 year

Other outcomes

  1. Hematological remission rate

    Time frame: after induction, approximately 6-8 weeks from diagnosis

  2. Molecular remission rate

    Time frame: after induction and consolidation, approximately 6-8 weeks from diagnosis

  3. Results of the positron emission tomography (PET) based remission evaluation

    Time frame: after consolidation, approximately 8-10 weeks

  4. Remission duration

    Time frame: up to 10 years

  5. Relapse rate

    Time frame: up to 10 years

  6. Overall survival

    Time frame: up to 10 years

  7. Relapse location

    Time frame: at timepoint of relapse (up to 10 years)

  8. Early death

    Time frame: during induction, approximately 6-8 weeks from diagnosis

  9. Death in clinical remission (CR)

    Time frame: during treatment, up to approximately 2.5 years from diagnosis

  10. Comorbidities according to Charlson Score

    Time frame: up to 2.5 years

  11. Quality of life assessed by QLQ-C30

    Time frame: up to 2.5 years

  12. Eastern Cooperative Oncology Group (ECOG) under therapy

    Time frame: up to 2.5 years

  13. Toxicity assessed by CTCAE v4.03

    Time frame: up to 2.5 years

  14. Results of the Dementia Detection (DemTect) test

    Time frame: up to 2.5 years

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2016
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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