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Sponsored by: |
University of Bologna |
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Information provided by: | University of Bologna |
ClinicalTrials.gov Identifier: | NCT00801580 |
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
Condition | Intervention | Phase |
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Lymphoid Leukemia |
Drug: doxorubicin liposomal |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label, Non-Randomized, Phase II Study on Fractioned Cyclophosphamide, Vincristine, Liposomal Doxorubicin or Doxorubicin, and Dexamethasone (MY HYPER-CVAD) in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia |
Estimated Enrollment: | 3 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
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Drug: doxorubicin liposomal
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of ALL (any type included), in patients who:
Exclusion Criteria:
Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
Contact: Giovanni Martinelli, MD | +39 051 6363829 | gmartino@alma.unibo.it |
Italy | |
Institute of Hematology "L. & A. Seragnoli" | Recruiting |
Bologna, Italy, 40138 |
Responsible Party: | Institute of Hematology "L. & A. Seragnoli" - University of Bologna ( Giovanni Martinelli ) |
Study ID Numbers: | ALL0206, Eudract: 2007-003884-30 |
Study First Received: | December 2, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00801580 |
Health Authority: | Italy: Ethics Committee |
relapsed ALL refractory ALL relapsed adult acute lymphoid leukemia |
Dexamethasone Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Rituximab Vincristine Cyclophosphamide Doxorubicin Acute lymphoblastic leukemia, adult |
Leukemia Lymphatic Diseases Methotrexate Hyperkinesis Lymphoproliferative Disorders Mesna Lymphoma Cytarabine Dexamethasone acetate |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |