Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3a Follicular Lymphoma
About this trial
This is an interventional treatment trial for Grade 1 Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible
- Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration
- Patients must have bone marrow biopsy performed within 42 days prior to registration
- Patients must have an indication for therapy as determined by the treating investigator
- All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form
The intent is to enroll patients with follicular lymphoma (FL) relapsed within 2 years of completing their first course of chemotherapy (CHOP or bendamustine based therapy) + anti-CD20 therapy. Patient is still eligible if he/she received radiation therapy or anti-CD20 therapy prior to chemoimmunotherapy or if maintenance anti-CD20 therapy was administered after chemoimmunotherapy
- Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine; relapsed patients must not have received any intervening chemotherapy
- Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine; (note that no minimum dose of bendamustine is required)
- Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible
- Patients who additionally received any maintenance anti-CD-20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible
Involved field or involved site radiation is not considered a line of therapy; examples of eligible prior treatment regimens (note this list is not all inclusive):
- 1st line rituximab treatment followed years later by bendamustine rituximab
- Bendamustine rituximab x 4 cycles
- 1st line rituximab treatment, 2nd line ibritumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance
- Bendamustine obinutuzumab x 3 cycles
- CHOP rituximab x 6 cycles followed by rituximab maintenance
- For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients prior treatment related toxicities (except alopecia) must have resolved to grade 1 or less prior to registration
- Patients must have tissue specimens collected prior to registration; patients must be offered participation in biobanking of residual specimens; with patient consent, residuals from the mandatory submission(s) will be banked for future research
- Patients must be >= 18 years of age
- All patients must have a Zubrod performance status of 0, 1 or 2
- Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration
- Platelets >= 75,000/mcL within 28 days prior to registration
- Patients must have adequate renal function as documented by a calculated creatinine clearance >= 60 mL/min, within 28 days prior to registration
- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert's syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
- Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (=< 5 x IULN secondary to lymphoma) within 28 days prior to registration
- Patients must have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 42 days prior to registration with a cardiac ejection fraction >= 45%
Patients with hepatitis B virus infection must have undetectable hepatitis B virus (HBV) on suppressive therapy and no evidence of HBV-related hepatic damage; patients with hepatitis C virus infection are eligible if complete eradication therapy has been successfully completed, and there is no detectable hepatitis C virus (HVC) or related hepatic damage; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria in addition to the other protocol eligibility criteria:
- Patient must have no history of acquired immune deficiency syndrome (AIDS)-related complications, other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
- Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
- Patient must have serum HIV viral load of < 200 copies/mm^3
- Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy; (recommend a regimen of the integrase inhibitor dolutegravir combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine)
- Protease inhibitors and once daily formulations containing cobicistat are NOT allowed due to potential pharmacokinetic interactions with leukemia therapy
- Stavudine and zidovudine (AZT) are NOT allowed because of overlapping toxicity with protocol therapy
- Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients unable or unwilling to take any listed prophylaxis are NOT eligible
- No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years
- Patients must have a complete history and physical examination within 28 days prior to registration
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal or post ovulation methods] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration
- Patients must have lactate dehydrogenase (LDH) and beta-2-microglobulin collected within 28 days prior to registration
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria:
- Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative
- Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide
Sites / Locations
- 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
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- PCR OncologyRecruiting
- Sutter Auburn Faith Hospital
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Kaiser Permanente DublinRecruiting
- Kaiser Permanente-FontanaRecruiting
- Kaiser Permanente-FremontRecruiting
- Kaiser Permanente-FresnoRecruiting
- Kaiser Permanente - Harbor CityRecruiting
- City of Hope at Irvine LennarRecruiting
- Kaiser Permanente-IrvineRecruiting
- Loma Linda University Medical Center
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Kaiser Permanente West Los AngelesRecruiting
- Memorial Medical Center
- Kaiser Permanente-ModestoRecruiting
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-OntarioRecruiting
- Palo Alto Medical Foundation Health Care
- VA Palo Alto Health Care SystemRecruiting
- Kaiser Permanente - Panorama CityRecruiting
- Eisenhower Medical Center
- Kaiser Permanente-RichmondRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Sutter Medical Center Sacramento
- Kaiser Permanente-South SacramentoRecruiting
- Kaiser Permanente - SacramentoRecruiting
- Kaiser Permanente-San Diego MissionRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Kaiser Permanente San LeandroRecruiting
- Kaiser Permanente-San MarcosRecruiting
- Kaiser Permanente-San RafaelRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa RosaRecruiting
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Kaiser Permanente-Woodland HillsRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- Boulder Community HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Denver Health Medical Center
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical CenterRecruiting
- Mercy Medical CenterRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Swedish Medical CenterRecruiting
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-LakewoodRecruiting
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical Center
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical CenterRecruiting
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer CenterRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical Center
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Parkview Hospital Randallia
- Parkview Regional Medical CenterRecruiting
- Reid Health
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran HospitalRecruiting
- Trinity Regional Medical CenterRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- Siouxland Regional Cancer CenterRecruiting
- Methodist West HospitalRecruiting
- Mercy Medical Center-West LakesRecruiting
- Cancer Center of Kansas - ChanuteRecruiting
- Cancer Center of Kansas - Dodge CityRecruiting
- Cancer Center of Kansas - El DoradoRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Cancer Center of Kansas-IndependenceRecruiting
- Cancer Center of Kansas-KingmanRecruiting
- Lawrence Memorial Hospital
- 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
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Cancer Center of Kansas - WichitaRecruiting
- Wesley Medical CenterRecruiting
- Cancer Center of Kansas - WinfieldRecruiting
- Flaget Memorial HospitalRecruiting
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Baton Rouge General Medical Center
- Hematology/Oncology Clinic PLLC
- Tulane University Health Sciences Center
- Ochsner Medical Center Jefferson
- Lahey Hospital and Medical Center
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer Center
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Beaumont Hospital - Dearborn
- Henry Ford Medical Center-FairlaneRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance HealthRecruiting
- West Michigan Cancer CenterRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Trinity Health Muskegon HospitalRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Lake Huron Medical Center
- Spectrum Health Reed City HospitalRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Mercy HospitalRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Essentia Health Hibbing ClinicRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- North Memorial Medical Health CenterRecruiting
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Essentia Health Virginia ClinicRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Parkland Health Center-Bonne Terre
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Capital Region Southwest CampusRecruiting
- Saint Luke's Hospital of Kansas City
- Kansas City Veterans Affairs Medical Center
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- Nebraska Medicine-BellevueRecruiting
- CHI Health Saint Francis
- CHI Health Good SamaritanRecruiting
- 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
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical CenterRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- University of New Mexico Cancer Center
- Roswell Park Cancer InstituteRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- North Shore University HospitalRecruiting
- Long Island Jewish Medical CenterRecruiting
- NYP/Weill Cornell Medical Center
- University of RochesterRecruiting
- Carolinas Medical Center/Levine Cancer Institute
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Wayne Memorial Hospital
- Margaret R Pardee Memorial Hospital
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- MetroHealth Medical CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Blanchard Valley Hospital
- Saint Rita's Medical CenterRecruiting
- Marietta Memorial HospitalRecruiting
- Toledo Clinic Cancer Centers-MaumeeRecruiting
- Licking Memorial HospitalRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Saint Ann's HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Bryn Mawr HospitalRecruiting
- Main Line Health Center-CollegevilleRecruiting
- Geisinger Medical CenterRecruiting
- Main Line Health Center-ExtonRecruiting
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Riddle Memorial HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Geisinger Medical Oncology-SelinsgroveRecruiting
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Lankenau Medical CenterRecruiting
- Medical University of South CarolinaRecruiting
- Saint Francis HospitalRecruiting
- Saint Francis Cancer CenterRecruiting
- Self Regional Healthcare
- Spartanburg Medical Center
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- M D Anderson Cancer CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- PeaceHealth Saint John Medical CenterRecruiting
- MultiCare Good Samaritan Hospital
- Swedish Medical Center-Ballard CampusRecruiting
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Swedish Medical Center-First HillRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- West Virginia University Charleston DivisionRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Arm I (obinutuzumab, umbralisib)
Arm II (obinutuzumab, lenalidomide)
Arm III (obinutuzumab, combination chemotherapy)
CLOSED TO ACCRUAL: Patients receive obinutuzumab IV on day 1 and umbralisib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.
Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.
PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.