SWOG clinical trial number
S1106
A Randomized Phase II Trial of R-HCVAD-MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients </= 65 Years of Age With Previously Untreated Mantle Cell Lymphoma
Closed
Phase
Accrual
29%
Published
Abbreviated Title
Randomized Phase II Younger Patients Mantle Cell Lymphoma
Activated
10/01/2011
Closed
06/26/2013
Participants
CTSU
Research committees
Lymphoma
Treatment
Cyclophosphamide
Dexamethasone
Vincristine
Doxorubicin
Methotrexate
Rituximab
Bendamustine
RT
Hyper-CVAD
Eligibility Criteria Expand/Collapse
All patients must have previously untreated Stage III, IV, or bulky Stage II mantle cell lymphoma (MCL). A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:
� CD19+ or CD20+ and
� Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH.
Pathology Review: Adequate sections from the original diagnostic specimen must be
available for submission for central review.
Patients must be ≥ 18 years and ≤ 65 years old. All patients must have bidimensionally measurable disease. A diagnostic quality CT scan of the neck, chest, abdomen, pelvis (with contrast) and PET scan must be performed within 28 days of registration. Patients must not have clinical evidence of central nervous system involvement by
lymphoma. Patients must have a unilateral or bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration. If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes.
All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan
within 42 days prior to registration. Patients with an ejection fraction < Institutional Lower Limit of Normal (ILLN) are not eligible.
Patients must be offered the opportunity to consent to the correlative science studies and for the use of tissue for future research. All patients must have a Zubrod performance status of 0 - 2. Patients must have adequate renal function as documented by a serum creatinine </= 2.0 x IULN. Patients must have adequate hepatic function documented by all of the following:
� Bilirubin < 3x IULN
� ALT and AST < 2.5x IULN
� Alkaline Phosphatase < 2.5x IULN
Patients must have a platelet count >/= 100,000/mcl unless due to bone marrow infiltration by lymphoma. Serum LDH and a CBC with differential must be measured (to calculate a Mantle Cell International Prognostic Indicator [MIPI] score).
Patients known to be HIV positive, or who have a history of solid organ transplantation
are ineligible due to concern over immunosuppression associated with B-cell depletion. Patients with active hepatitis are not eligible. Patients must be eligible for stem cell transplant by institutional guidelines with the plan that transplant will be conducted at a cooperative group approved transplant center
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. Patient must not be pregnant or nursing due to the potential for congenital
abnormalities and of harm to nursing infants due to this treatment regimen. Women or
men of reproductive potential must have agreed to use an effective contraceptive method.
� CD19+ or CD20+ and
� Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH.
Pathology Review: Adequate sections from the original diagnostic specimen must be
available for submission for central review.
Patients must be ≥ 18 years and ≤ 65 years old. All patients must have bidimensionally measurable disease. A diagnostic quality CT scan of the neck, chest, abdomen, pelvis (with contrast) and PET scan must be performed within 28 days of registration. Patients must not have clinical evidence of central nervous system involvement by
lymphoma. Patients must have a unilateral or bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration. If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes.
All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan
within 42 days prior to registration. Patients with an ejection fraction < Institutional Lower Limit of Normal (ILLN) are not eligible.
Patients must be offered the opportunity to consent to the correlative science studies and for the use of tissue for future research. All patients must have a Zubrod performance status of 0 - 2. Patients must have adequate renal function as documented by a serum creatinine </= 2.0 x IULN. Patients must have adequate hepatic function documented by all of the following:
� Bilirubin < 3x IULN
� ALT and AST < 2.5x IULN
� Alkaline Phosphatase < 2.5x IULN
Patients must have a platelet count >/= 100,000/mcl unless due to bone marrow infiltration by lymphoma. Serum LDH and a CBC with differential must be measured (to calculate a Mantle Cell International Prognostic Indicator [MIPI] score).
Patients known to be HIV positive, or who have a history of solid organ transplantation
are ineligible due to concern over immunosuppression associated with B-cell depletion. Patients with active hepatitis are not eligible. Patients must be eligible for stem cell transplant by institutional guidelines with the plan that transplant will be conducted at a cooperative group approved transplant center
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. Patient must not be pregnant or nursing due to the potential for congenital
abnormalities and of harm to nursing infants due to this treatment regimen. Women or
men of reproductive potential must have agreed to use an effective contraceptive method.
Publication Information Expand/Collapse
2019
2017
PMid: PMID27992063 | PMC number: PMC5318240
2015
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