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High-Dose Sequential Chemoimmunotherapy for B-Cell Lymphomas With Central Nervous System Involvement (SCNSL1)

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ClinicalTrials.gov Identifier: NCT00801216
Recruitment Status : Unknown
Verified October 2008 by IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : December 3, 2008
Last Update Posted : December 3, 2008
Sponsor:
Collaborator:
Mundipharma K.K.
Information provided by:
IRCCS San Raffaele

Brief Summary:
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 or disease Intervention/treatment Phase
B-Cell Lymphomas Drug: High-dose sequential chemotherapy and autologous transplant Phase 2

IRCCS San Raffaele has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: High-dose sequential chemoimmunotherapy
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)
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)
Other Name: Depocyte



Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. Response duration [ Time Frame: 2-year ]
  2. Overall survival [ Time Frame: 2-year ]
  3. Tolerability [ Time Frame: 2-year ]
  4. Neurotoxicity [ Time Frame: 2-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma
  2. CNS involvement (brain, meninges, cranial nerves, eyes, and/or spinal cord) at diagnosis or relapse after conventional chemotherapy
  3. Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated.
  4. Age 19-65 years
  5. ECOG performance status 0-3
  6. Adequate bone marrow (PLT > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3), renal (creatinine clearance > 60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gammaGT < 2.5 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement)
  7. Absence of symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
  8. Absence of HIV infection
  9. No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers without evidence of disease at least from 5 years
  10. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  11. Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
  12. No treatment with other experimental drugs within the 6 weeks previous to enrolment
  13. Give written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801216


Contacts
Contact: Andrés J. Ferreri, MD 0039-02-2643 7649 andres.ferreri@hsr.it
Contact: Stefania Trinca 0039-02-2643 4289 stefania.trinca@hsr.it

Locations
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         
Sponsors and Collaborators
IRCCS San Raffaele
Mundipharma K.K.
Investigators
Study Chair: Andrés J. Ferreri, MD San Raffaele Scientific Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrés J.M. Ferreri, San Raffaele Scientific Institute
ClinicalTrials.gov Identifier: NCT00801216     History of Changes
Other Study ID Numbers: SCNSL1
IIL-SCNSL-1
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: October 2008

Keywords provided by IRCCS San Raffaele:
B-cell lymphomas
lymphomatous meningitis
liposomal cytarabine
autologous transplant
CNS involvement
Secondary CNS lymphomas

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Cytarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents