Spots Global Cancer Trial Database for Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma
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Trial Identification
Brief Title: Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma
Official Title: A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).
Study ID: NCT00195871
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chr de La Citadelle, Liege, , Belgium
Cliniques Universitaires U C L de Mont Godinne, Yvoir, , Belgium
C H U D'Angers, Angers, , France
Centre Hospitalier de La Region Annecienne, Annecy, , France
Chu de Grenoble, Grenoble, , France
Centre Hospitalier de Lens, Lens, , France
Edouard Herriot Hospital, Lyon, , France
Pierre Benite Hospital, Lyon, , France
Institut Paoli Calmettes, Marseilles, , France
Saint-Louis Hospital, Paris, , France
La Pitie Salpetriere Hospital, Paris, , France
Cochin Hospital, Paris, , France
Marechal Joffre Hospital, Perpignan, , France
Centre Hospitalier de Poitiers, Poitiers, , France
Chu de Reims Robert Debre Hospital, Reims, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancerologie de La Loire, Saint Priest En Jarez, , France
Bretonneau Hospital, Tours, , France
Chu de Brabois, Vandoeuvre Les Nancy, , France
Contact Details
Name: Stephane Lepretre, MD
Affiliation: Centre Henri Becquerel, Rouen, France
Role: STUDY_CHAIR
Name: Hervé Dombret, MD
Affiliation: Saint-Louis Hospital, Paris, France
Role: PRINCIPAL_INVESTIGATOR
Name: Norbert Ifrah, MD
Affiliation: Centre Hospitalier Universitaire d'Angers, FRANCE
Role: PRINCIPAL_INVESTIGATOR
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