SWOG clinical trial number
S0601

A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma

Closed
Phase
Accrual
100%
Published
Abbreviated Title
NON-HODGKINS: R-CHOP-V followed by VM maintenance therapy for MCL
Activated
08/15/2006
Closed
06/01/2008
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Lymphoma

Treatment

Rituximab Bortezomib CHOP

Eligibility Criteria Expand/Collapse

Previously untreated Stage III, IV, or bulky Stage II mantle cell lymphoma (MCL);

MCL diagnosis must be confirmed by IHC or flow cytometry documenting the following phenotypes: (1)CD19+ (or CD20+); (2) Cyclin D1+ (or evidence of the t(11;14) translocation by cytogenetics or FISH);

Adequate sections from original specimen must be available for pathology review;

>= age 18;

PS=0-2;

Must not have clinical evidence of CNS involvement by lymphoma;

Must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma;

Must not be HIV+;

Must not have >= Grade 2 peripheral neuropathy within 14 days prior to registration;

Must not have known hypersensitivity to bortezomib, boron, or mannitol;

Must not have received other investigational drugs within 14 days of registration;

Must not be pregnant or nursing; confirmation by negative hCG pregnancy test must be obtained prior to registration (pregnancy testing is not required for post-menopausal or surgically sterilized women);

Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method;

No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Labs and scans (w/in 28 days prior to registration): Assessment for bidimensionally measurable disease; serum LDH; diagnostic CT scan of the chest and abdomen/pelvis with contrast; PET scan (a PET/CT scan can be done instead of separate PET and CT scans if the CT component is a diagnostic CT w/ contrast).

Labs and scans (w/in 42 days prior to registration): Assessment for non-measurable disease; unilateral bone marrrow aspirate and biopsy for staging; If the biopsy cannot be performed by the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes

Publication Information Expand/Collapse

2019

Evaluation of Patient Risk Factors in Bortezomib-induced Peripheral Neuropathy in SWOG Trial S0601

J de Guzman;H Li;B Till;R Beuttler;S-F Wong American Association of Colleges of Pharmacy (AACP) Annual meeting (7/13-17/19, Chicago, IL

2016

Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for mantle cell lymphoma: SWOG S0601

BG Till;H Li;S Bernstein;RI Fisher;RW Burack;LM Rimsza;J Floyd;M DaSilva;D Moore, Jr.;O Pozdnyakova;SM Smith;M Leblanc;JW Friedberg British Journal of Haematology, Jan;172(2):208-218; 2015 Oct 22[Epub ahead of print]

PMid: PMID26492567 | PMC number: PMC4710555

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

2014

Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for previously untreated mantle cell lymphoma: SWOG 0601

B Till;H Li;S Bernstein;RI Fisher;WR Burack;L Rimsza;JD Floyd;M DaSilva;D Moore;M Leblanc;JW Friedberg Blood 124(21):149, 2014; American Society for Hematology (December 6-9, 2014, San Francisco, CA), oral;