POLARGO: A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study Details
Study Description
Brief Summary
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx in 206 participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pola-R-GemOx (Stage 1) Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
Drug: Polatuzumab Vedotin
polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Drug: Rituximab
rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Drug: Gemcitabine
gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Drug: Oxaliplatin
oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
|
| Experimental: Pola-R-GemOx (Stage 2) Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg/cycle administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
Drug: Polatuzumab Vedotin
polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Drug: Rituximab
rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Drug: Gemcitabine
gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Drug: Oxaliplatin
oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
|
| Active Comparator: R-GemOx (Stage 2) Participants will receive rituximab 375 milligrams per square meter (mg/m^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration. |
Drug: Rituximab
rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Drug: Gemcitabine
gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Drug: Oxaliplatin
oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
|
Outcome Measures
Primary Outcome Measures
- Stage 1: Percentage of Participants with Adverse Events (AEs) [From baseline until 90 days after last dose]
- Stage 2: Overall Survival (OS) [From randomization until end of study (up to approximately 25 months)]
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Secondary Outcome Measures
- Stage 1: Percentage of Participants with Peripheral Neuropathy [From baseline up to approximately 44 months]
Peripheral neuropathy will be measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item Scale (FACT-GOG/Ntx12). FACT-GOG/Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy.
- Stage 1: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions [From baseline until 28 days after last dose]
- Stage 1: Polatuzumab Vedotin Dose Intensity [From baseline until 28 days after last dose]
Dose intensity is defined as the ratio of actual dose administered versus intended dose.
- Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline [Baseline]
- Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline [Baseline up until Month 2 of the Post-Treatment Follow-up period]
- Stage 1: Percentage of Participants with Complete Response (CR) [From baseline up to approximately 44 months]
CR was defined as complete metabolic response assessed by the investigator through PET-CT Scan according to Lugano 2014 response criteria.
- Stage 1: Percentage of Participants with Objective Response (OR) [From baseline up to approximately 44 months]
OR is defined as complete metabolic response (CR) or partial metabolic response (PR) and will be assessed by the investigator through PET-CT scan according to Lugano 2014 response criteria.
- Stage 1: Best Overall Response (BOR) [From baseline up to approximately 44 months]
BOR is defined as the best response recorded from the start of treatment until end of treatment (based on PET-CT or CT data) according to Lugano 2014 response criteria, determined by the investigator
- Stage 1: Progression Free Survival (PFS) [From baseline up to approximately 44 months]
PFS is defined as the time from enrollment to the first occurrence of disease progression (as determined by the investigator according to Lugano 2014 response criteria) or death.
- Stage 1: Overall Survival (OS) [From baseline up to approximately 44 months]
OS is defined as the time from enrollment to death from any cause.
- Stage 1: Event Free Survival (EFS) [From baseline up to approximately 44 months]
EFS is defined as the time from enrollment to the first occurrence of disease progression or relapse, death due to any cause or initiation of any non-protocol-specified antilymphoma treatment (NALT).
- Stage 2: Percentage of Participants with Objective Response (OR) [From randomization until up to 25 months]
OR is defined as CR or PR and will be assessed by an Independent review committee through PET-CT scan according to Lugano 2014 response criteria. OR will also be assessed by the investigator using Response alone (not including PET data) and will consider complete response instead of complete metabolic response.
- Stage 2: Percentage of Participants with Complete Response (CR) [From randomization until up to 25 months]
CR will be assessed by an Independent review committee through PET-CT scan according to Lugano 2014 response criteria. CR will also be assessed by the Investigator using Response (not including PET data) and will consider complete response instead of complete metabolic response.
- Stage 2: Best Overall Response (BOR) [From randomization until up to 25 months]
BOR is defined as the best response recorded from the start of treatment until end of treatment (based on PET-CT or CT data) according to Lugano 2014 response criteria, determined by the investigator
- Stage 2: Progression Free Survival (PFS) [From randomization until up to 25 months]
PFS is defined as the time from the time of randomization to the first occurrence of disease progression (as determined by the investigator according to Lugano 2014 response criteria) or death.
- Stage 2: Duration of Response (DOR) [From randomization until up to 25 months]
DOR will be assessed in patients who had an OR, as determined by the investigator, using Lugano 2014 response criteria. DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.
- Stage 2: Event Free Survival (EFS) [From randomization until up to 25 months]
EFS is defined as the time from enrollment to the first occurrence of disease progression or relapse, death due to any cause or initiation of NALT.
- Stage 2: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 25 months)]
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
- Stage 2: Time to Deterioration in Physical Functioning and Fatigue [Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 25 months)]
Time to deterioration in physical functioning and fatigue is defined as the time from randomization to the first documentation of a 10-point decrease in EORTC QLQ-C30 physical functioning and fatigue scales from baseline. The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
- Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score [Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 25 months)]
The FACT-Lym is a validated health-related quality of life (HRQoL) instrument used specifically in patients with lymphoma. It is composed of the 27-item FACT-general questionnaire (FACT-G), which measures health-related quality of life in patients undergoing any type of cancer therapy, plus the 15-item Lymphoma-Specific Subscale (FACT-Lym LYMS), which assesses the HRQoL impacts of more lymphoma-specific symptoms. Each item of the FACT-Lym is answered using a 5-point scale ranging from 0 = "not at all" to 4 = "very much". 0 = Not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = Very much. FACT-LYM total score can be calculated and higher scores are reflective of better HRQoL.
- Stage 2: Time to Progression in Lymphoma Symptoms According to FACT-Lym Subscale [Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 25 months)]
Time to progression is defined as the time from randomization to the first documentation of a 3-point decrease (clinically meaningful change) from baseline.
- Stage 2: Change from Baseline in Peripheral Neuropathy According to FACT/GOG-NTX-12 Subscale Score [Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 25 months)]
FACT/GOG-Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy. It is answered using a 5-point scale ranging from 0 = "not at all" to 4 = "very much". 0 = Not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = Very much. FACT/GOG-Ntx12 subscale scores can be calculated with higher scores reflective of a better outcome.
- Stage 2: Percentage of Participants with Adverse Events (AEs) [From randomization until up to 25 months]
- Stage 2: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions [From randomization until up to 25 months]
- Stage 2: Polatuzumab Vedotin Dose Intensity [From randomization until up to 25 months]
Dose intensity is defined as the ratio of actual dose administered versus intended dose.
- Stage 2: Percentage of Participants with Peripheral Neuropathy [From randomization until up to 25 months]
Peripheral neuropathy will be measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item Scale (FACT-GOG/Ntx12). FACT-GOG/Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy.
- Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline [Baseline]
- Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline [Baseline up until Month 2 of the Post-Treatment Follow-up period]
Other Outcome Measures
- Stage 1: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL) [Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)]
Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
- Stage 2: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL) [Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)]
Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
-
Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that progressed during therapy or progressed within 6 months (< 6 months) of prior therapy)
-
At least one (≥ 1) line of prior systemic therapy:
-
Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; chemotherapy followed by consolidative autologous HSCT will be counted as one line of therapy
-
Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; chemotherapy followed by allogeneic HSCT will be counted as one line of therapy
-
Local therapies (e.g., radiotherapy) will not be considered as lines of treatment
-
At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
-
Adequate hematological function
-
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
-
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm,
Exclusion Criteria:
-
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
-
Contraindication to rituximab, gemcitabine or oxaliplatin
-
Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0
-
Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks
-
Planned autologous or allogenic stem cell transplantation at time of recruitment
-
Primary or secondary central nervous system (CNS) lymphoma
-
Richter's transformation or prior CLL
-
Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
-
Vaccination with a live vaccine within 4 weeks prior to treatment
-
Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
-
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
-
Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
-
Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 2 | Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | United States | 32256 |
| 3 | Memorial Cancer Institute at Memorial West | Pembroke Pines | Florida | United States | 33028 |
| 4 | St. Joseph Mercy - Brighton | Brighton | Michigan | United States | 48114 |
| 5 | St. Joseph Mercy - Canton | Canton | Michigan | United States | 48188 |
| 6 | St. Joseph Mercy - Chelsea | Chelsea | Michigan | United States | 48118-1370 |
| 7 | IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center | Ypsilanti | Michigan | United States | 48197 |
| 8 | Oncology Hematology Associates - Springfield | Springfield | Missouri | United States | 65807 |
| 9 | Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska | United States | 68130 |
| 10 | MSKCC at Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 11 | Memorial Sloan Kettering - Monmouth | Middletown | New Jersey | United States | 07748 |
| 12 | Memorial Sloan Kettering Cancer Center at Bergen | Montvale | New Jersey | United States | 07645 |
| 13 | MSKCC @ Commack | Commack | New York | United States | 11725 |
| 14 | The Cancer Institute at St Francis Hospital | East Hills | New York | United States | 11548 |
| 15 | Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York | United States | 10604 |
| 16 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 17 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 18 | Baptist Memorial Hospital | Memphis | Tennessee | United States | 38120 |
| 19 | Millennium Research & Clinical Development | Houston | Texas | United States | 77090 |
| 20 | Hospital Sao Rafael - HSR | Salvador | BA | Brazil | 41253-190 |
| 21 | Liga Norte Riograndense Contra O Câncer | Natal | RN | Brazil | 59040150 |
| 22 | Hospital das Clinicas - UFRGS | Porto Alegre | RS | Brazil | 90035-903 |
| 23 | Hospital das Clinicas - FMUSP | Sao Paulo | SP | Brazil | 05403-900 |
| 24 | London Health Sciences Centre | London | Ontario | Canada | N6A 4L6 |
| 25 | Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site | St. Catharines | Ontario | Canada | L2R 7C6 |
| 26 | McGill University Health Centre - Glen Site | Montreal | Quebec | Canada | H4A 3J1 |
| 27 | Centre hospitalier regional de Trois-Rivieres | Trois-Rivieres | Quebec | Canada | G8Z 3R9 |
| 28 | Hu Nan Provincial Cancer Hospital | Changsha | China | 410006 | |
| 29 | West China Hospital - Sichuan University | Chengdu City | China | 610047 | |
| 30 | Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology | Guangzhou City | China | 510060 | |
| 31 | Zhujiang Hospital, Southern Medical University | Guangzhou | China | 510280 | |
| 32 | The 1st Affiliated Hospital of Nanchang Unversity | Nanchang | China | 330019 | |
| 33 | Guangxi Cancer Hospital of Guangxi Medical University | Nanning | China | 530021 | |
| 34 | Institute of Hematology and Hospital of Blood Disease | Tianjin City | China | 300020 | |
| 35 | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | China | 430023 | |
| 36 | First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | China | 710061 | |
| 37 | Helsinki University Central Hospital; Dept of Oncology | Helsinki | Finland | 00250 | |
| 38 | Kuopio Uni Hospital; Oncology Dept | Kuopio | Finland | 70211 | |
| 39 | Oulu University Hospital; Oncology | Oulu | Finland | 90029 | |
| 40 | Tampere University Hospital; Dept of Oncology | Tampere | Finland | 33520 | |
| 41 | Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny | Creteil | France | 94010 | |
| 42 | CHU de Nîmes - Hôpital Carémeau | Nimes | France | 30029 | |
| 43 | Hopital De Haut Leveque; Hematologie Clinique | Pessac | France | 33604 | |
| 44 | Centre Henri Becquerel; Service Hématologie | Rouen | France | 76038 | |
| 45 | ICANS | Strasbourg | France | 67200 | |
| 46 | Hopital Bretonneau; Hematologie Therapie Cellulaire | TOURS Cedex | France | 37044 | |
| 47 | Gemeinschaftsklinikum Mittelrhein gGmbH; Ev. Stift St. Martin | Koblenz | Germany | 56068 | |
| 48 | Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo. | Ulm | Germany | 89081 | |
| 49 | Laiko General Hospital; Hematology Clinic | Athens | Greece | 115 27 | |
| 50 | Attiko Hospital; Haematology Clinic | Athens | Greece | 124 62 | |
| 51 | Tata Memorial Hospital | Mumbai | Maharashtra | India | 400013 |
| 52 | Tata Medical Center | Kolkata | WEST Bengal | India | 700160 |
| 53 | All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital; Department of Oncology | New Delhi | India | 110029 | |
| 54 | Cork University Hospital | Cork | Ireland | ||
| 55 | St James' Hospital; Cancer Clinical Trials Office | Dublin | Ireland | ||
| 56 | Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia | Modena | Emilia-Romagna | Italy | 41123 |
| 57 | Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia | Roma | Lazio | Italy | 00133 |
| 58 | Osp. San Raffaele; Dip. Di Oncoematologia | Milano | Lombardia | Italy | 20132 |
| 59 | Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica | Bari | Puglia | Italy | 70124 |
| 60 | ARNAS Garibaldi; Ematologia | Catania | Sicilia | Italy | 95122 |
| 61 | USL 4 di Prato - Nuovo Ospeale di Prato | Prato | Toscana | Italy | 59100 |
| 62 | Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova | Padova | Veneto | Italy | 35128 |
| 63 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 64 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
| 65 | Gyeongsang National University Hospital | Gyeongsangnam-do | Korea, Republic of | 52727 | |
| 66 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
| 67 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 68 | Health Pharma Professional Research | Cdmx | Mexico CITY (federal District) | Mexico | 03100 |
| 69 | Instituto Nacional de Cancerologia; Oncology | Distrito Federal | Mexico | 14080 | |
| 70 | Hospital de Especialidades Centro Medico Nacional La Raza; Haematology | Mexico City | Mexico | 02990 | |
| 71 | Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia | Badalona | Barcelona | Spain | 08915 |
| 72 | Hospital Universitario de Canarias;servicio de Hematologia | La Laguna | Tenerife | Spain | 38320 |
| 73 | Hospital Univ. 12 de Octubre; Servicio de Hematologia | Madrid | Spain | 28041 | |
| 74 | Hospital Clinico Universitario de Salamanca;Servicio de Hematologia | Salamanca | Spain | 37007 | |
| 75 | Hospital Universitario Dr. Peset; Servicio de Hematologia | Valencia | Spain | 46017 | |
| 76 | Akademiska sjukhuset, Onkologkliniken | Uppsala | Sweden | 751 85 | |
| 77 | Sakarya Universitesi Egitim ve Arastirma Hastanesi | Adapazari/Sakarya | Turkey | 54100 | |
| 78 | Abdurrahman Yurtarslan Onkoloji Training and Research Hospital | Ankara | Turkey | 06200 | |
| 79 | Akdeniz Uni School of Medicine; Hematology | Antalya | Turkey | 07059 | |
| 80 | Istanbul Uni Istanbul Medical Faculty | Istanbul | Turkey | 34093 | |
| 81 | Istanbul University Cerrahpasa Medical Faculty; Hematology Department | Istanbul | Turkey | 34098 | |
| 82 | Kocaeli Universitesi Tip Fakultesi | Kocaeli | Turkey | 41380 | |
| 83 | Amerikan HAstanesi Onkoloji Birimi Teşvikiye | Nişantaşı | Turkey | 34365 | |
| 84 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0YN | |
| 85 | Kings College Hospital | London | United Kingdom | SW9 8RR | |
| 86 | Nottingham City Hospital; Dept of Haematology | Nottingham | United Kingdom | NG5 1PB |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MO40598
- 2018-003727-10