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A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

NCT04224493 · Ipsen
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Official title
Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma
About this study
Stage 1 of the study, which is now completed, looked at the safety and tolerability of the drug combinations and helped determine the recommended dose for the next stages. In Stage 2, participants will be grouped based on whether they have a specific genetic mutation called EZH2. All participants will receive treatment in 28-day cycles. After 12 cycles, they will continue with maintenance treatment using either the study drug or a placebo, depending on their original group. The study will include participants with and without the EZH2 mutation. Enrollment may be completed separately for each group. In China, some participants will also have extra blood tests to better understand how the drug behaves in the body. Stage 3 will focus on long-term follow-up to monitor how well the treatment works, how safe it is, and how long participants live. All participants will be followed for up to 5 years after the last person joins the study
Eligibility criteria
Inclusion Criteria: 1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. 2. Males or females are ≥18 years of age, or per country adult legal age regulations, at the time of providing voluntary written informed consent. 3. Life expectancy ≥3 months before enrollment. 4. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows * Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis. * Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation * If HIV positive, HIV infection is controlled. Based on Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections - Guidance for Industry (https://www.fda.gov/media/121319/download), patients with HIV should be considered eligible if they have CD4+ T-cell counts ≥ 350 cells/uL and in general, if they have not had an opportunistic infection within the past 12 months. Other exclusion criteria should be considered regarding the drug-drug interaction if antiviral drugs are used. Therefore, in case of controlled HIV infection, since antiviral drugs are used, trial patients should be on established ART for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrolment. 5. Have histologically confirmed FL, Grades 1 to 3A. 6. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy: a. Systemic therapy includes treatments such as: i. Rituximab monotherapy ii. Chemotherapy given with or without rituximab iii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab. b. Systemic therapy does not include, for example: i. Local involved field radiotherapy for limited-stage disease ii. Helicobacter pylori eradication c. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a. d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed. e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed. 7. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression \<6 months after last dose). 8. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5). 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 10. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant. 11. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification a. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled. Tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 24 months prior to the anticipated administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable. NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor. 12. Time between prior anticancer therapy and first dose of tazemetostat as follows: 1. Cytotoxic chemotherapy - At least 21 days. 2. Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days. 3. Nitrosoureas - At least 6 weeks. 4. Monoclonal and/or bispecific antibodies or CAR T - At least 28 days. 5. Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation. 13. Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula. 14. Adequate bone marrow function: a. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10\^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10\^9/L) with bone marrow infiltration * Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days. b. Platelets ≥75,000/mm3 (≥75 × 10\^9/L) * Evaluated at least 7 days after last platelet transfusion. c. Hemoglobin ≥9.0 g/dL * May receive transfusion 15. Adequate liver function: 1. Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome. 2. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver infilration). 16. International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended. 17. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin \[β-hCG\] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic \[amenorrhea following cancer therapy does not rule out childbearing potential\] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing). 18. Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception: Examples of highly effective methods: * Intrauterine device (IUD) * Hormonal (ovulation inhibitory combined \[estrogen and progesterone\] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[e.g. desogestrel\]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction. * Bilateral tubal ligation * Partner's vasectomy (if medically confirmed \[azoospermia\] and sole sexual partner). Examples of additional effective methods: * Male latex or synthetic condom, * Diaphragm, * Cervical Cap NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception. 19. All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme \[PPP\] in Europe) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used. a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in theapplicable pregnancy prevention program. During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, at day 14 (for FCBP with irregular menstrual cycles) and day 28 following the last dose of lenalidomide and at overall treatment discontinuation (at the End-of-Treatment/30-day safety Follow-up visit). Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR are surgically sterilized (ie, total hysterectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study treatment. 20. Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation. NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation. Exclusion Criteria: All Subjects 1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2. 2. Prior exposure to lenalidomide or drugs of the same class. 3. Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled). 4. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN). 5. Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL). 6. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases. 7. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort). 8. Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study. 9. Major surgery within 4 weeks before the first dose of study drug. a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment. 10. Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat. 11. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. 12. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome. 13. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat. a. Note: Participants who have experienced deep vein thrombosis/pulmonary embolism more than 3 months before enrollment are eligible but are recommended to receive prophylaxis. 14. Have an active infection requiring systemic therapy. 15. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation. 16. Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA. NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody \[anti-HBs\] positive, and HBV core antibody \[anti-HBc\] negative) are eligible. 17. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus. NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible. 18. Any other medical or social condition that, in the Investigator's judgment, will interfere with a participant's ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject's participation in the study, or that may interfere with interpretation of results. 19. Female subjects who are pregnant or lactating/breastfeeding. 20. Subjects who have undergone a solid organ transplant. 21. Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Study design
Enrollment target: 612 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2020-06-11
Estimated completion: 2029-03-01
Last updated: 2026-03-02
Interventions
Drug: TazemetostatDrug: TazemetostatDrug: Placebo oral tabletCombination Product: LenalidomideCombination Product: Rituximab
Primary outcomes
  • Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2) (Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1)
  • Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population (Stage 2: Up to 72 months)
  • PFS in the Intent-to-treat mutant-type (ITT-MT) population (Stage 2: Up to 72 months)
Sponsor
Epizyme, Inc. · industry
Contacts & investigators
ContactIpsen Clinical Study Enquiries · contact · clinical.trials@ipsen.com · See e mail
InvestigatorIpsen Medical Director · study_director, Ipsen
All locations (229)
Southern Cancer CenterRecruiting
Mobile, Alabama, United States
Arizona Oncology Associates - Tuscon-Rusadill RoadRecruiting
Tucson, Arizona, United States
TOI - Clinical ResearchRecruiting
Cerritos, California, United States
UCSF FresnoRecruiting
Clovis, California, United States
UC San Diego Health SciencesRecruiting
La Jolla, California, United States
UCLA Clinical Research Unit Hematology/OncologyRecruiting
Santa Monica, California, United States
Rocky Mountain Cancer Centers (RMCC) - BoulderRecruiting
Boulder, Colorado, United States
St. Mary's Hospital and Regional Medical Center - St. Mary'sRecruiting
Grand Junction, Colorado, United States
SCL Health Lutheran Medical CenterWithdrawn
Greeley, Colorado, United States
Cancer Specialists of North FloridaRecruiting
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer CenterTerminated
Fort Myers, Florida, United States
Mayo Clinic - Cancer Clinical Research OfficeWithdrawn
Jacksonville, Florida, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Miami Cancer InstituteWithdrawn
Miami, Florida, United States
Florida Cancer Affiliates/Ocala Oncology - ClinicRecruiting
Ocala, Florida, United States
BRCR Medical Center, INCRecruiting
Plantation, Florida, United States
Florida Cancer SpecialistsRecruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists - PanhandleRecruiting
Tallahassee, Florida, United States
H Lee Moffitt Cancer Center and Research Institute IRecruiting
Tampa, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - AtlantisRecruiting
West Palm Beach, Florida, United States
Kaiser Permanente Hawaii Moanalua Medical CenterWithdrawn
Honolulu, Hawaii, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Illinois Cancer SpecialistsRecruiting
Niles, Illinois, United States
June E. Nylen Cancer CenterWithdrawn
Sioux City, Iowa, United States
The University of Kansas Cancer CenterWithdrawn
Overland Park, Kansas, United States
University of MarylandWithdrawn
Baltimore, Maryland, United States
The office of Frederick P. Smith, MD, P.C.Withdrawn
Chevy Chase, Maryland, United States
Mass General Cancer Center at Newton-WellesleyWithdrawn
Newton, Massachusetts, United States
University of Michigan Comprehensive Cancer CenterRecruiting
Ann Arbor, Michigan, United States
St. Joseph Mercy HospitalRecruiting
Ypsilanti, Michigan, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Saint Louis University Cancer CenterWithdrawn
St Louis, Missouri, United States
University Of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Astera Cancer CenterRecruiting
East Brunswick, New Jersey, United States
Regional Cancer Care Associates-FreeholdRecruiting
Freehold, New Jersey, United States
Hackensack University Medical John Theurer Cancer CenterWithdrawn
Hackensack, New Jersey, United States
Regional Cancer Care Associates LLC - HowellWithdrawn
Howell Township, New Jersey, United States
Regional Cancer Care Associates LLC - Little SilverRecruiting
Little Silver, New Jersey, United States
New Mexico Cancer Care AllianceRecruiting
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C.Withdrawn
Albany, New York, United States
Northwell Health/Monter Cancer CenterWithdrawn
Lake Success, New York, United States
Weill Cornell Medicine-New York Presbyterian HospitalRecruiting
New York, New York, United States
Columbia U - Herbert Irving Comprehensive Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Hematology Oncology Associates of Rockland, P.C.Recruiting
Nyack, New York, United States
Messino Cancer CenterRecruiting
Asheville, North Carolina, United States
Levine Cancer Institute - ConcordRecruiting
Concord, North Carolina, United States
FirstHealth of the CarolinasRecruiting
Pinehurst, North Carolina, United States
Regional Medical Oncology CenterRecruiting
Wilson, North Carolina, United States
Gabrail Cancer Center ResearchRecruiting
Canton, Ohio, United States
Oncology Hematology Care (OHC), Inc. - Kenwood OfficeRecruiting
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center - OncologyRecruiting
Eugene, Oregon, United States
University of Pittsburgh Medical Center - OncologyWithdrawn
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital Hematology & Cellular TherapyRecruiting
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLCWithdrawn
Chattanooga, Tennessee, United States
University of Tennessee Medical Center - Cancer InstituteWithdrawn
Knoxville, Tennessee, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Texas Oncology - AmarilloRecruiting
Amarillo, Texas, United States
Texas Oncology-Austin MidtownRecruiting
Austin, Texas, United States
Texas Oncology - Medical City Dallas Pediatric HematologyRecruiting
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Millennium Physicians - OncologyTerminated
Houston, Texas, United States
Texas OncologyRecruiting
Plano, Texas, United States
Mays Cancer CenterRecruiting
San Antonio, Texas, United States
UT Health East Texas HOPE Cancer Center - TylerRecruiting
Tyler, Texas, United States
USO Texas Oncology - TylerRecruiting
Tyler, Texas, United States
Texas Oncology- WeslacoRecruiting
Weslaco, Texas, United States
Utah Cancer Specialists/ IHO CorpRecruiting
Salt Lake City, Utah, United States
Huntsman Cancer Institute; The University of UtahRecruiting
Salt Lake City, Utah, United States
Peninsula Cancer InstituteWithdrawn
Chesapeake, Virginia, United States
Virginia Cancer SpecialistsRecruiting
Gainesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Inc.Recruiting
Roanoke, Virginia, United States
MC Rockwood Cancer Bl Specialty Ctr - NorthWithdrawn
Spokane, Washington, United States
Yakima Valley Memorial Hospital - North Star Lodge Cancer CenterWithdrawn
Yakima, Washington, United States
Wheeling HospitalRecruiting
Wheeling, West Virginia, United States
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Barwon Health, University Hospital GeelongRecruiting
Geelong, Victoria, Australia
Hollywood Private HospitalRecruiting
Nedlands, Western Australia, Australia
GenesisCare - St Andrew'sRecruiting
Adelaide, Australia
Peninsula Health - FrankstonRecruiting
Frankston, Australia
Royal Hobart HospitalRecruiting
Hobart, Australia
Gold Coast University HosptialRecruiting
Southport, Australia
CHU Dinant Godinne UCL NamurWithdrawn
Yvoir, Namur, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven - Campus GasthuisbergRecruiting
Leuven, Vlaams Brabant, Belgium
Hospital Haroldo Juacaba - Instituto do Cancer do CearaRecruiting
Ceará, Brazil
Hospital Santa CruzRecruiting
Curitiba, Brazil
HC-UFG - Hospital das CLINICAS da Universidade Federal de GoRecruiting
Goiânia, Brazil
Association Hospital de Caridade de IjuRecruiting
Ijuí, Brazil
Liga Norte Riograndense Contra o CancerRecruiting
Natal, Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa ClinicaRecruiting
Porto Alegre, Brazil
Instituto D'Or de Pesquisa e Ensino- RecifeRecruiting
Recife, Brazil
Instituto de Psiquiatria - UFRJRecruiting
Rio de Janeiro, Brazil
Instituto Nacional de Câncer - INCARecruiting
Rio de Janeiro, Brazil
Fundacao Antonio Prudente - Hospital A.C.Camargo Cancer CenterRecruiting
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)Recruiting
São Paulo, Brazil
Instituto D'or de Pesquisa e EnsinoRecruiting
São Paulo, Brazil
Instituto de Oncologia e Hematologia - HEMOMEDRecruiting
São Paulo, Brazil
Irmandade Santa Casa de Misericordia de Sao PauloRecruiting
São Paulo, Brazil
University Health Network Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
Montreal, Quebec, Canada
Sir Mortimer B Davis/Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Nova Scotia Health Centre for Clinical ResearchRecruiting
Nova Scotia, Canada
Sunnybrook Health Sciences Centre Odette Cancer CentreRecruiting
Ottawa, Canada
Fujian Medical University Union HospitalRecruiting
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, Fujian, China
The Affiliated Hospital of Guizhou Medical UniversityRecruiting
Guiyang, Guizhou, China
The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
Zhejiang, Hangzhou, China
The Fourth Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, Hebei, China
Henan Provincial People's HospitalRecruiting
Zhengzhou, Henan, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
The First Bethune Hospital of Jilin UniversityRecruiting
Changchun, Jinlin, China
The Affiliated Hospital of Qingdao UniversityRecruiting
Qingdao, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Shanxi Bethune HospitalRecruiting
Taiyuan, Shanxi, China
Peking University Third HospitalRecruiting
Beijing, China
The First Affiliated Hospital Zhejiang University School of MedicineRecruiting
Hangzhou, China
Tongji Hospital of Tongji Medical College of HUSTRecruiting
Hangzhou, China
Jiangxi Cancer HospitalRecruiting
Nanchang, China
Shandong Cancer HospitalRecruiting
Shandong, China
Tongji Hospital of Tongji UniversityRecruiting
Shanghai, China
Sichuan Provincial People's HospitalRecruiting
Sichuan, China
Tianjin Medical University Cancer Institute & HospitalRecruiting
Tianjin, China
Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut LevequeRecruiting
Pessac, Aquitaine, France
CHRU Brest Hôp MorvanRecruiting
Brest, Brittany Region, France
Institut BergonieRecruiting
Bordeaux, Gironde, France
Centre Hosp Mulh Hop Emile MullerRecruiting
Mulhouse, Haut-Rhin, France
Centre Henri BecquerelRecruiting
Rouen, Haute-Normandie, France
CHU de Limoges DupuytrenRecruiting
Limoges, Haute-Vienne, France
CHU de Grenoble - Hopital AlbeRecruiting
La Tronche, Isere, France
CHU de Nantes - HematologieRecruiting
Nantes, Loire-Atlantique, France
CHRU de Lille Hop Claude HuriezRecruiting
Lille, Nord, France
Centre Hospitalier Le MansRecruiting
Le Mans, Sarthe, France
Centre Hospitalier Universitaire D'Angers - Hématologie CliniqueRecruiting
Angers, France
CHRU de Besançon- Hopital Jean MinjozRecruiting
Besançon, France
CHU CaenWithdrawn
Caen, France
CHU de Clermont-Ferrand, site EstaingRecruiting
Clermont-Ferrand, France
Centre Hospitalier Docteur SchaffnerRecruiting
Lens, France
L'Hôpital Privé ConfluentRecruiting
Nantes, France
L'hôpital Privé du ConcluentRecruiting
Nantes, France
Hopital Saint LouisRecruiting
Paris, France
Centre Hospitalier - Hôpital de jour d'HématologieRecruiting
Périgueux, France
Centre Hospitalier Universitaire de PoitiersRecruiting
Poitiers, France
CHU de Nancy BraboisRecruiting
Vandœuvre-lès-Nancy, France
Centre Hospitalier Bretagne AtlantiqueRecruiting
Vannes, France
Institut Gustave RoussyRecruiting
Villejuif, France
Hopital Henri Mondor - Hemopathies LymphoidesRecruiting
Créteil, Île-de-France Region, France
Diakoneo Diak Schwaebisch Hall gGmbHRecruiting
Schwäbisch Hall, Baden-Wurttemberg, Germany
Klinikum Der Universität München AöRRecruiting
München, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universitat MuencheWithdrawn
München, Bavaria, Germany
Universitätsmedizin MainzRecruiting
Mainz, Hesse, Germany
Universitaetsklinikum Bonn AöRRecruiting
Bonn, North Rhine-Westphalia, Germany
Kliniken Maria Hilf GmbHRecruiting
Mönchengladbach, North Rhine-Westphalia, Germany
Städt. Krankenhaus KielRecruiting
Kiel, Schleswig-Holstein, Germany
Vivantes Klinikum am Urban Hämatologie und OnkologieRecruiting
Berlin, Germany
University Medical Center Schleswig HolsteinRecruiting
Kiel, Germany
Debreceni Egyetem Klinikai KözpontRecruiting
Debrecen, Hajdú-Bihar, Hungary
Semmelweis Egyetem Általános Orvostudományi KarRecruiting
Budapest, Hungary
Országos Onkológiai IntézetRecruiting
Budapest, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai IntezetWithdrawn
Budapest, Hungary
AOU Federico IIRecruiting
Naples, Campania, Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCSRecruiting
Meldola, Forli-Cesena, Italy
ASST Spedali Civili di BresciaRecruiting
Brescia, Italy
PO Garibaldi-Nesima, ARNAS GaribaldiRecruiting
Catania, Italy
AOU CareggiRecruiting
Florence, Italy
Ospedale Vito Fazzi, ASL LecceRecruiting
Lecce, Italy
IEO - Istituto Europeo di Oncologia, IRCCSRecruiting
Milan, Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' GrandaRecruiting
Milan, Italy
Ospedale Niguarda, ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Ospedale San Gerardo, ASST di MonzaRecruiting
Monza, Italy
Ospedale Civile S.Spirito, PO di Pescara, AUSL PescaraRecruiting
Pescara, Italy
Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e NovafeltriaRecruiting
Rimini, Italy
Catholic University Of Sacred HeartRecruiting
Roma, Italy
PU Campus Bio-Medico di RomaTerminated
Roma, Italy
Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCSRecruiting
Roma, Italy
Azienda Ospedaliera Santa Maria di TerniRecruiting
Terni, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di TorinoRecruiting
Torino, Italy
Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca TrevigianaRecruiting
Treviso, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale MaggioreRecruiting
Trieste, Italy
Centrum Medyczne Pratia PoznanRecruiting
Skórzewo, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut BadawczyRecruiting
Warsaw, Masovian Voivodeship, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.Withdrawn
Słupsk, Poland
MICS Centrum Medyczne TorunRecruiting
Torun, Poland
MTZ Clinical Research powered by PratiaRecruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we WroclawiuRecruiting
Wroclaw, Poland
National Cancer Center SingaporeRecruiting
Singapore, Singapore
Tan Tock Seng HospitalRecruiting
Singapore, Singapore
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Samsung Medical CenterRecruiting
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, South Korea
Ajou University HospitalRecruiting
Suwon, South Korea
Hospital Universitari Vall d'HebrónRecruiting
Barcelona, Cataluny, Spain
Hospital Costa del SolRecruiting
Marbella, Málaga, Spain
Hospital Del MarRecruiting
Barcelona, Spain
Hospital Virgen de la ArrixacaRecruiting
El Palmar, Spain
Hospital Univ. Infanta LeonorRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Clínica Universidad de NavarraRecruiting
Madrid, Spain
C.H. de NavarraRecruiting
Pamplona, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
Hospital Universitario Nuestra Señora de ValmeRecruiting
Seville, Spain
Hospital Universitario Virgen De La MacarenaRecruiting
Seville, Spain
Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi HospitalRecruiting
Hualien City, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-OncologyRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Ankara University Medical Faculty - HematologyRecruiting
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and ResearchRecruiting
Ankara, Turkey (Türkiye)
Gazi University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Medipol Bagcilar Mega HospitalRecruiting
Istanbul, Turkey (Türkiye)
Ondokuz Mayis University Medical Faculty - HematologyRecruiting
Samsun, Turkey (Türkiye)
Western General Hospital - HaematologyRecruiting
Edinburgh, Edinburgh, City of, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith HospitalRecruiting
London, London City, United Kingdom
St Bartholomew's Hospital Barts Health NHS TrustRecruiting
London, London, City of, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer CentreRecruiting
Bebington, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall HospitalRecruiting
Cornwell, United Kingdom
Beatson West of Scotland Cancer CentreRecruiting
Glasgow, United Kingdom
Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJRecruiting
Middlesex, United Kingdom
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. · TrialPath