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
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
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
2016
PMid: PMID26492567 | PMC number: PMC4710555
Recommendations for clinical trial development in mantle cell lymphoma
PMid: PMID28040733 | PMC number: PMC n/a - Review
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