Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
NCT ID: NCT00689845
Last Updated: 2009-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2007-06-30
Brief Summary
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PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.
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Detailed Description
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Primary
* To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma.
* To determine the PET response rate following chemoimmunotherapy in these patients.
Secondary
* To obtain data, on a nonrandomized basis, regarding the outcomes of treatment using different chemoimmunotherapy regimens and using or omitting mediastinal radiotherapy, depending upon the practice of the participating institutions.
* To analyze progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive any one of the following standard chemoimmunotherapy regimens.
* Cohort 1 (R-CHOP-21): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
* Cohort 2 (R-CHOP-14): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
* Cohort 3 (R-MACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
* Cohort 4 (R-VACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
* Cohort 5 (R-ACVBP): Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Patients with an International Prognostic Index score of 4 or greater or disease in close proximity to the spinal cord or cerebral meninges may receive prophylactic treatment to the CNS according to local protocol.
Beginning 8 weeks after completion of chemoimmunotherapy, patients undergo radiotherapy to the original tumor volume according to local protocol.
Fresh or fixed tissue from prior biopsy is obtained if possible. Samples are analyzed for CD3, CD20, CD30, CD15, CD10, Bcl-6, Bcl-2, MAL protein (if available), and Ki-67 via immunohistochemistry.
After completion of study treatment, patients are followed periodically.
Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
Study Groups
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Cohort 1
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
rituximab
given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
prednisolone
Given orally
vincristine sulfate
Given IV
Cohort 2
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
filgrastim
Given subcutaneously
rituximab
given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
prednisolone
Given orally
vincristine sulfate
Given IV
Cohort 3
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
bleomycin sulfate
Given IV
rituximab
given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
methotrexate
Given IV
prednisolone
Given orally
vincristine sulfate
Given IV
Cohort 4
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
bleomycin sulfate
Given IV
rituximab
given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
etoposide phosphate
Given IV
prednisolone
Given orally
vincristine sulfate
Given IV
Cohort 5
Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
bleomycin sulfate
Given IV
filgrastim
Given subcutaneously
rituximab
given IV
cyclophosphamide
Given IV
cytarabine
Given subcutaneously
doxorubicin hydrochloride
Given IV
etoposide phosphate
Given IV
ifosfamide
Given IV
methotrexate
Given IV
prednisone
Given orally
vindesine
Given IV
Interventions
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bleomycin sulfate
Given IV
filgrastim
Given subcutaneously
rituximab
given IV
cyclophosphamide
Given IV
cytarabine
Given subcutaneously
doxorubicin hydrochloride
Given IV
etoposide phosphate
Given IV
ifosfamide
Given IV
methotrexate
Given IV
prednisolone
Given orally
prednisone
Given orally
vincristine sulfate
Given IV
vindesine
Given IV
Eligibility Criteria
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Exclusion Criteria
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Able and willing to give informed consent and to undergo staging, including PET scanning
PRIOR CONCURRENT THERAPY:
* No prior treatment for lymphoma
* Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms
18 Years
ALL
No
Sponsors
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University Hospital Southampton NHS Foundation Trust
OTHER
Principal Investigators
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Peter Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Southampton NHS Foundation Trust
Locations
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Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Saint Bartholomew's Hospital
London, , United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
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USCTU-IELSG-26-RHM-CAN0546
Identifier Type: -
Identifier Source: secondary_id
EU-20818
Identifier Type: -
Identifier Source: secondary_id
EudraCT 2006-005794-22
Identifier Type: -
Identifier Source: secondary_id
USCTU-07/Q1704/68
Identifier Type: -
Identifier Source: secondary_id
CDR0000588011
Identifier Type: -
Identifier Source: org_study_id
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