Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission
CD20 Positive, Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for CD20 Positive
Eligibility Criteria
Inclusion Criteria:
- INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
- Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until Step 1 registration. Patients may register to Step 0 without a documented Ki-67 index.
- Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician
Patient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0
- For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); patients preregistered post-induction with evidence of clinical disease progression are not eligible for preregistration
Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
- NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen
- Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement
Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence
- NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient?s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment
- INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
- Patients must have met eligibility criteria for the screening step
Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:
- Patients are ?MRD Indeterminate?: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR
- ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
Patients must have completed induction therapy within 120 days prior to preregistration to step 0, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (?day 0?) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given
- Patient must have received at least four (4) cycles of induction therapy
Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
- NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen
- Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria
- Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements
- Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the below criteria:
- HIV is sensitive to antiretroviral therapy
- Must be willing to take effective antiretroviral therapy if indicated
- CD4 count at screening >= 300 cells/mm^3
- No history of acquired immune deficiency syndrome (AIDS)-defining conditions
- Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months
Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy CenterRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- Kingman Regional Medical CenterRecruiting
- University of Arizona Cancer Center-Orange Grove CampusRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- PCR OncologyRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- UCSF Medical Center-ParnassusRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of AuroraRecruiting
- Boulder Community HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Cancer Center of Colorado at Sloan's LakeRecruiting
- Denver Health Medical Center
- National Jewish Health-Main CampusRecruiting
- The Women's Imaging CenterRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph HospitalRecruiting
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical CenterRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Swedish Medical CenterRecruiting
- National Jewish Health-Western Hematology OncologyRecruiting
- Saint Mary's Hospital and Regional Medical CenterRecruiting
- Grand Valley Oncology
- North Colorado Medical CenterRecruiting
- Rocky Mountain Cancer Centers-Greenwood Village
- Good Samaritan Medical CenterRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical CenterRecruiting
- McKee Medical CenterRecruiting
- National Jewish Health-Northern Hematology OncologyRecruiting
- SCL Health Lutheran Medical CenterRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Baptist MD Anderson Cancer CenterRecruiting
- Mayo Clinic in FloridaRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Augusta University Medical CenterRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Mountain States Tumor InstituteRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Medical CenterRecruiting
- Walter Knox Memorial HospitalRecruiting
- Saint Luke's Mountain States Tumor Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Mountain States Tumor Institute - MeridianRecruiting
- Saint Alphonsus Medical Center-NampaRecruiting
- Saint Luke's Mountain States Tumor Institute - NampaRecruiting
- Kootenai Cancer CenterRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Mountain States Tumor Institute-Twin FallsRecruiting
- Loyola Center for Health at Burr RidgeRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-GottliebRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Loyola Center for Cancer Care and ResearchRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Sidney and Lois Eskenazi HospitalRecruiting
- Cancer Center of Kansas - ChanuteRecruiting
- Cancer Center of Kansas - Dodge CityRecruiting
- Cancer Center of Kansas - El DoradoRecruiting
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-IndependenceRecruiting
- Cancer Center of Kansas-KingmanRecruiting
- Lawrence Memorial HospitalRecruiting
- Cancer Center of Kansas-LiberalRecruiting
- Cancer Center of Kansas-ManhattanRecruiting
- Cancer Center of Kansas - McPhersonRecruiting
- Cancer Center of Kansas - NewtonRecruiting
- Cancer Center of Kansas - ParsonsRecruiting
- Cancer Center of Kansas - PrattRecruiting
- Cancer Center of Kansas - SalinaRecruiting
- Cancer Center of Kansas - WellingtonRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Cancer Center of Kansas - WichitaRecruiting
- Cancer Center of Kansas - WinfieldRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Huron Medical Center PC
- Lake Huron Medical Center
- Mayo ClinicRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Saint Louis University HospitalRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Saint Vincent HealthcareRecruiting
- Saint Vincent Frontier Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment CenterRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Saint Peter's Community Hospital
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- Nebraska Medicine-BellevueRecruiting
- Nebraska Medicine-Village PointeRecruiting
- University of Nebraska Medical CenterRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-HendersonRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- 21st Century Oncology-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West SurgeryRecruiting
- OptumCare Cancer Care at OakeyRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Cancer and Blood Specialists-ShadowRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- 21st Century OncologyRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland ParkwayRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-San MartinRecruiting
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- 21st Century Oncology-Vegas TenayaRecruiting
- Ann M Wierman MD LTDRecruiting
- Cancer and Blood Specialists-TenayaRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-TenayaRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical CenterRecruiting
- 21st Century Oncology-Fort ApacheRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial HillsRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Roswell Park Cancer Institute
- Glens Falls HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Wake Forest University at ClemmonsRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- Duke University Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- University of Cincinnati/Barrett Cancer CenterRecruiting
- Case Western Reserve UniversityRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- University PointeRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Saint Alphonsus Medical Center-Baker CityRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Saint Charles Health System-RedmondRecruiting
- Geisinger Medical CenterRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- Medical University of South CarolinaRecruiting
- Prisma Health Cancer Institute - LaurensRecruiting
- Prisma Health Cancer Institute - EasleyRecruiting
- Saint Francis HospitalRecruiting
- Prisma Health Cancer Institute - ButternutRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
- Saint Francis Cancer CenterRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Prisma Health Cancer Institute - SpartanburgRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Houston Methodist HospitalRecruiting
- Methodist Willowbrook Hospital
- Houston Methodist Sugar Land Hospital
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Farmington Health CenterRecruiting
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of UtahRecruiting
- LDS Hospital
- South Jordan Health CenterRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer CenterRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- MultiCare Auburn Medical Center
- Overlake Hospital Medical CenterRecruiting
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Providence Regional Cancer PartnershipRecruiting
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson Healthcare
- MultiCare Good Samaritan Hospital
- Valley Medical CenterRecruiting
- Pacific Gynecology SpecialistsRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Seattle Cancer Care AllianceRecruiting
- Kaiser Permanente Washington
- Swedish Medical Center-First HillRecruiting
- Swedish Medical Center-Cherry HillRecruiting
- University of Washington Medical CenterRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-SheltonRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- Providence Regional Cancer System-YelmRecruiting
- United Hospital CenterRecruiting
- WVUH-Berkely Medical CenterRecruiting
- West Virginia University HealthcareRecruiting
- Camden Clark Medical CenterRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Mayo Clinic Health System-Eau Claire Clinic
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- University of Wisconsin Hospital and ClinicsRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Medical Center
- Medical College of WisconsinRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Clinic Stevens Point CenterRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Marshfield Clinic - Weston CenterRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
- Cheyenne Regional Medical Center-WestRecruiting
- Billings Clinic-CodyRecruiting
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (auto-HCT, rituximab)
Group II (rituximab alone)
Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab IV once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.