Clinical trial · Interventional
Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
- 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)
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt's Leukemia | Burkitt Leukemia | ALIAS | 0.90 |
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| Large Cell Anaplastic Lymphoma | — | UNRESOLVED | — |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mediastinal Neoplasms | Mediastinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone/Prednisolone | Drug | — | UNRESOLVED |
| G-CSF | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Irradiation (in specific conditions) | Procedure | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
- interventionNames
- Drug: Adriamycin
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Dexamethasone/Prednisolone
- Drug: VP16
- Drug: Ifosfamide
- Drug: Methotrexate
- Drug: G-CSF
- Drug: Rituximab
- Drug: Vincristine/Vindesine
- Procedure: Irradiation (in specific conditions)
Primary outcomes (4)
- measure
- Remission rate
- measure
- Remission duration
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma * Age \> 15 years * Written informed consent Exclusion Criteria: * Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected * HIV infection * Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy * Known severe allergy to foreign proteins * Pre-treatment other than 1 cycle CHOP or similar; \< 1 week of another chemotherapy. * Pregnancy or nursing * Participation in other studies that interfere with study therapy
References
Publications (1)
- RESULTHoelzer D, Walewski J, Dohner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Duhrsen U, Huttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gokbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30. PMID 25359988