SWOG clinical trial number
S0213

Pilot Trial of Hyper-CVAD and Methotrexate/ARA C+ Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Mantle Cell Lymphoma
Activated
10/01/2002
Closed
09/01/2006
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Lymphoma

Treatment

Cytosine Arabinoside Cyclophosphamide Dexamethasone Vincristine Filgrastim Leucovorin Calcium Mesna Methotrexate Rituximab Hyper-CVAD

Eligibility Criteria Expand/Collapse

Newly diagnosed, previously untreated, biopsy proven Stage III/IV or bulky Stage II mantle cell lymphoma of either nodular, diffuse, mantle zone or blastic subtype; No prior radiation therapy or chemotherapy for lymphoma; No prior treatment with a monoclonal antibody; Adequate diagnostic specimen available for pathology review (needle aspirations or cytologies are not adequate); Serum bilirubin < or = 1.5 mg/dl; serum creatinine < or =2.0 mg/dl; Creatinine clearance >50 ml/min; ANC > or = 1,000/mm3 and platelets > or =100,000/mm3; Cardiac ejection fraction >/=50%; EKG with no significant abnormalities; Bidimensionally measurable disease; No known hypersensitivity to E. Coli derived proteins; Willing to receive transfusions of blood products; No pregnant or nursing women; PS 0-2; No known AIDS syndrome or HIV associated complex; Between the ages of 18 and 70.

Publication Information Expand/Collapse

2016

Recommendations for clinical trial development in mantle cell lymphoma

S Spurgeon;B Till;P Martin;A Goy;M Dreyling;A Gopal;M Leblanc;JP Leonard;JW Friedberg;L Baizer;R Little;BS Kahl;MR Smith Journal of the National Cancer Institute, Dec 31;109(1). pii: djw263

PMid: PMID28040733 | PMC number: PMC n/a - Review

2013

A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients < 70 years of age with previously untreated mantle cell lymphoma: SWOG 0213

S Bernstein;E Epner;J Unger;M LeBlanc;E Cebula;WR Burack;L Rimsza;TP Miller;RI Fisher Annals of Oncology 24(6):1587-1593;

PMid: PMID23504948 | PMC number: PMC3660082

2007

A multi center trial of hyperCVAD+rituxan in patients with newly diagnosed mantle cell lymphoma

EM Epner;J Unger;T Miller;L Rimsza;C Spier;M LeBlanc;R Fisher Blood 110(11):#387