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| ID | Type | Description | Link |
|---|---|---|---|
| GMALL-STI571-ELDERLY-01/02 |
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The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib | Drug | |||
| vincristine | Drug | |||
| cyclophosphamide | Drug | |||
| cytosine arabinoside | Drug | |||
| dexamethasone | Drug | |||
| idarubicin | Drug | |||
| methotrexate (intrathecal) | Drug | |||
| AraC (intrathecal) |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate after induction therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate during induction | ||
| Severe adverse events during induction | ||
| Efficacy of salvage therapy after crossover |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver G Ottmann, M.D. | Contact | ++49-69-6301-0 | 6221 | ottmann@em.uni-frankfurt.de |
| Barbara Wassmann, M.D. | Contact | ++49-69-6301-0 | 6221 | wassmann@em.uni-frankfurt.de |
| Name | Affiliation | Role |
|---|---|---|
| Oliver G Ottmann, M.D. | Medizinische Klinik II, Johann Wolfgang Goethe Universität | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Klinik II, Johann Wolfgang Goethe Universität | Recruiting | Frankfurt am Main | 60590 | Germany |
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| Drug |
| dexamethasone (intrathecal) | Drug |
| Levels of minimal residual disease |
| Incidence of relapse |
| Remission duration |
| Disease free survival |
| Overall survival |
| Frequency of point mutations in the BCR-ABL gene |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D015255 | Idarubicin |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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