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The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.
Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide | Drug | coventional dosages |
| |
| hematopoietic stem cell allograft | Procedure | conventional procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | 2 y |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities. | 2 y |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane Lepretre, MD | Centre Henri Becquerel, Rouen, France | Study Chair |
| Hervé Dombret, MD | Saint-Louis Hospital, Paris, France | Principal Investigator |
| Norbert Ifrah, MD | Centre Hospitalier Universitaire d'Angers, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chr de La Citadelle | Liège | 4000 | Belgium | |||
| Cliniques Universitaires U C L de Mont Godinne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14576732 | Background | Le Gouill S, Lepretre S, Briere J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4. doi: 10.1038/sj.leu.2403095. |
| Label | URL |
|---|---|
| Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French) | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 31, 2016 | |
| Reset | Oct 21, 2016 |
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| Yvoir |
| 5530 |
| Belgium |
| C H U D'Angers | Angers | 49033 | France |
| Centre Hospitalier de La Region Annecienne | Annecy | 74011 | France |
| Chu de Grenoble | Grenoble | 38043 | France |
| Centre Hospitalier de Lens | Lens | 62300 | France |
| Edouard Herriot Hospital | Lyon | 69437 | France |
| Pierre Benite Hospital | Lyon | 69495 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Saint-Louis Hospital | Paris | 75000 | France |
| La Pitie Salpetriere Hospital | Paris | 75013 | France |
| Cochin Hospital | Paris | 75014 | France |
| Marechal Joffre Hospital | Perpignan | 66046 | France |
| Centre Hospitalier de Poitiers | Poitiers | 86000 | France |
| Chu de Reims Robert Debre Hospital | Reims | 51092 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut de Cancerologie de La Loire | Saint-Priest-en-Jarez | 42271 | France |
| Bretonneau Hospital | Tours | 37044 | France |
| Chu de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 31, 2016 | Oct 21, 2016 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008223 | 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 |
|---|---|
| D011241 | Prednisone |
| D014750 | Vincristine |
| D003630 | Daunorubicin |
| D003520 | Cyclophosphamide |
| D001215 | Asparaginase |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
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