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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adriamycin | Drug |
| ||
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate | ||
| Remission duration | ||
| Disease free survival | ||
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Dose and time compliance | ||
| Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) | ||
| Death under therapy and in complete remission (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Goekbuget, Dr. med. | University Hospital of Frankfurt (Main) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Medical Dept. II | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25359988 | Result | Hoelzer 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. |
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|
| Cytarabine | Drug |
|
| Dexamethasone/Prednisolone | Drug |
|
| VP16 | Drug |
|
| Ifosfamide | Drug |
|
| Methotrexate | Drug |
|
| G-CSF | Drug |
|
| Rituximab | Drug |
|
| Vincristine/Vindesine | Drug |
|
| Irradiation (in specific conditions) | Procedure |
|
| Localisations of relapse |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D008479 | Mediastinal Neoplasms |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D016399 | Lymphoma, T-Cell |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D011239 | Prednisolone |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D008727 | Methotrexate |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069283 | Rituximab |
| D014750 | Vincristine |
| D014751 | Vindesine |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D055585 | Physical Phenomena |
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