NCT02881086CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1023 (actual)
- First submitted
- 4 Aug 2016
- Start date
- Aug 2016
- Primary completion date
- Dec 2024
- Lead sponsor
- Goethe University
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT02881086
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1023
- From Aug 2016 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials interfering with the study therapy
Other illness
- Late relapse of pediatric ALL or ALL as second malignancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
Other
- Severe comorbidity or leukemia associated complications
- Cytostatic pre-treatment
- Pregnancy or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Frankfurt (Main) Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
Related publications
- CD20 expression dynamics in adult B-cell acute lymphoblastic leukemia and impact on anti-CD20 treatment.J Hematol Oncol · 2026 · PMID 42477805
This page is information, not medical advice. Discuss any trial with your doctor.