Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (19)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Cranial irradiation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin (DNR) | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Imatinib |
Design
Arms and outcomes
Arms (9)
- type
- OTHER
- label
- Stratification I - Standard Risk (SR)/ High Risk (HR)
- description
- 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
- interventionNames
- Drug: Rituximab
- Drug: PEG-Asparaginase
- Drug: Dexamethasone
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Mercaptopurine
- Drug: VP16
- Drug: Daunorubicin (DNR)
- Drug: Methotrexate
- Drug: Cytarabine
- Drug: Vindesine
- type
- OTHER
- label
- Stratification I - Philadelphia (PH)+
- description
- Induction and consolidation I therapy for PH+ patients Chemotherapy, immunotherapy, intrathecal prophylaxis Drugs: Rituximab, Vincristine, Imatinib, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, VP16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSzczepanowski M, Richter J, Bendig S, Bastian L, Kelm M, Beck V, Beder T, Chitadze G, Kotrova M, Duell J, Faul C, Gartner J, Hartmann A, Kehden B, Penas EMM, Neumann M, Ritgen M, Schrader W, Steffen B, Trautmann H, Viardot A, Burmeister T, Baldus CD, Schwartz S, Gokbuget N, Bruggemann M. CD20 expression dynamics in adult B-cell acute lymphoblastic leukemia and impact on anti-CD20 treatment. J Hematol Oncol. 2026 Jul 20;19(1):52. doi: 10.1186/s13045-026-01832-4. PMID 42477805