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Sponsors and Collaborators: |
IRCCS San Raffaele Mundipharma K.K. |
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Information provided by: | IRCCS San Raffaele |
ClinicalTrials.gov Identifier: | NCT00801216 |
This prospective trial will assess the activity and feasibility of a new high-dose methotrexate-based high-dose sequential chemotherapy combination in patients with B-cell lymphomas and CNS involvement at diagnosis or relapse. Selected drugs, with a well-documented anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier penetration and CNS bioavailability as well as to reduce potential cross-resistance.
Condition | Intervention | Phase |
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B-Cell Lymphomas |
Drug: High-dose sequential chemotherapy and autologous transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High-Dose Sequential Chemotherapy and Rituximab (R-HDS) in Patients With Systemic B-Cell Lymphoma With Central Nervous System Involvement at Diagnosis or Relapse |
Estimated Enrollment: | 38 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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High-dose sequential chemoimmunotherapy: Experimental
Two courses of methotrexate 3.5 g/mq day 1 and cytarabine 2 g/mq twice a day, for two days, Rituximab 375 mg/mq days 3 & 11 and Intrathecal liposomal cytarabine 50 mg day 6(Phase I) followed in case of response by cyclophosphamide 7 g/mq plus Rituximab 375 mg/mq and Intrathecal liposomal cytarabine 50 mg Leukapheresis A and cryopreservation (Phase II), Cytarabine 2 g/mq twice a day for 4 days, Rituximab 375 mg/m2 and Reinfusion of stem cells (Phase III), etoposide 2 g/mq, Intrathecal liposomal cytarabine 50 mg (Phase IV) and high-dose Thiotepa-BCNU supported by autologous stem cell transplant (Phase V), and whole-brain radiotherapy in patients who do not achieve a complete remission after chemotherapy (Phase VI)
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Drug: High-dose sequential chemotherapy and autologous transplant
Two courses of methotrexate 3.5 g/mq day 1 and cytarabine 2 g/mq twice a day, for two days, Rituximab 375 mg/mq days 3 & 11 and Intrathecal liposomal cytarabine 50 mg day 6(Phase I) followed in case of response by cyclophosphamide 7 g/mq plus Rituximab 375 mg/mq and Intrathecal liposomal cytarabine 50 mg Leukapheresis A and cryopreservation (Phase II), Cytarabine 2 g/mq twice a day for 4 days, Rituximab 375 mg/m2 and Reinfusion of stem cells (Phase III), etoposide 2 g/mq, Intrathecal liposomal cytarabine 50 mg (Phase IV) and high-dose Thiotepa-BCNU supported by autologous stem cell transplant (Phase V), and whole-brain radiotherapy in patients who do not achieve a complete remission after chemotherapy (Phase VI)
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Patients with aggressive B-cell lymphoma and involvement of the central nervous system at diagnosis or relapse will be treated with a combination of high-dose methotrexate and high-dose cytarabine, rituximab, and intrathecal depocyte followed by rituximab-high-dose sequential chemotherapy supported by autologous tsem cell transplantation.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrés J. Ferreri, MD | 0039-02-2643 7649 | andres.ferreri@hsr.it |
Contact: Stefania Trinca | 0039-02-2643 4289 | stefania.trinca@hsr.it |
Italy | |
San Raffaele Scientific Institute | Recruiting |
Milan, Italy, 20132 | |
Contact: Roberto Crocchiolo, MD roberto.crocchiolo@hsr.it | |
Contact: Silvia Govi, MD silvia.govi@hsr.it | |
Sub-Investigator: Andrea Assanelli, MD | |
San Raffaele Scientific Institute | Recruiting |
Milan, Italy, 20132 | |
Sub-Investigator: Roberto Crocchiolo, MD | |
Sub-Investigator: Silvia Govi, MD |
Study Chair: | Andrés J. Ferreri, MD | San Raffaele Scientific Institute |
Responsible Party: | San Raffaele Scientific Institute ( Andrés J.M. Ferreri ) |
Study ID Numbers: | SCNSL1, IIL-SCNSL-1 |
Study First Received: | November 28, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801216 |
Health Authority: | United States: Food and Drug Administration; Italy: Ministry of Health |
B-cell lymphomas lymphomatous meningitis liposomal cytarabine |
autologous transplant CNS involvement Secondary CNS lymphomas |
Immunoproliferative Disorders Rituximab Cyclophosphamide Etoposide phosphate Thiotepa Meningitis Lymphoma, B-Cell Lymphatic Diseases |
B-cell lymphomas Neoplasm Metastasis Methotrexate Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Etoposide Lymphoma Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors |
Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |