PACIFICA: A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Study Details
Study Description
Brief Summary
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients)
Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis
Intervention/treatment: Drug-Pacritinib
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The study is a randomized, controlled phase 3 study comparing the efficacy of pacritinib with P/C therapy in patients with PMF, PPV-MF, or PET-MF (Dynamic International Prognostic Scoring System [DIPSS] risk score of Intermediate-1 to High-Risk), who have had had no or limited exposure to any JAK2 inhibitor or are JAK2 inhibitor-naive, and who have severe thrombocytopenia (platelet count <50,000/µL). This study was designed to use the pacritinib 200 mg BID dose, which was determined to be the optimal dose based on dose- and exposure-response analyses conducted using all available data, including the dosing data from the previous portion of this study. Patients will be randomized 2:1 to receive pacritinib 200 mg BID or the P/C therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization. Randomization will be stratified by prior JAK2 inhibitor therapy (yes/no) and P/C therapy selected prior to randomization. Prior JAK2 inhibitor therapy will be defined as any duration of treatment with a JAK2 inhibitor, such as ruxolitinib, fedratinib, or momelotinib. To be eligible, patients are not allowed to have been treated with more than one JAK2 inhibitor. Assigned treatment will continue until the patient experiences progressive disease or intolerable AEs, withdraws consent, or initiates new MF-directed therapy. No study treatment crossover will be allowed at any time. All patients should complete all visit procedures through Week 24, including patients who stop treatment or have protocol-defined progressive disease prior to Week 24, unless the patient withdraws consent for study procedures, dies, undergoes splenic irradiation or splenectomy, initiates any non-protocol-directed anti-MF treatment, or the study is terminated. In addition to the above, patients will be considered to have discontinued treatment if pacritinib or P/C therapy is held for >28 consecutive days due to treatment toxicity, or if treatment is discontinued for lack of efficacy, or at the request of the principal investigator or the patient. Following the Week 24 assessment, patients who are benefiting from therapy will be allowed to continue receiving the assigned treatment (pacritinib or P/C) until the patient experiences progressive disease, intolerable AEs, withdraws consent, or initiates new MF-directed therapy. All randomized patients will be followed for survival for 2.5 years from the date of randomization unless consent for follow-up is withdrawn.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pacritinib 200 mg BID To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food |
Drug: Pacritinib
Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base
|
Active Comparator: Physician's Choice (P/C) therapy The Physician's Choice (P/C) therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization. |
Drug: Physician's Choice medications
Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Spleen volume [From baseline at 24 weeks]
To compare the efficacy of pacritinib with that of physician's choice (P/C) therapy, as assessed by the proportion of patients achieving a ≥35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans
- Total Symptom Score (TSS) [From baseline at Week 24]
To compare the efficacy of pacritinib with P/C therapy, as assessed by the proportion of patients achieving a ≥50% reduction in Total Symptom Score (TSS). The TSS is the sum of the individual symptom scores for tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under ribs on the left side. Symptoms are ranked 0 (absent) to 10 (worst imaginable)
Secondary Outcome Measures
- Overall Survival (OS) [until 2.5 years after the date of randomization]
To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C
- Patient Global Impression of Change (PGIC) assessed at Week 24 [End of Week 12 to 2 years following Week 24 visit]
To compare the percentage of patients who self-assess as "very much improved" or "much improved" as measured by the Patient Global Impression of Change (PGIC) in patients treated with pacritinib versus those treated with P/C
- To compare the safety of pacritinib versus P/C therapy [Randomization through 30 after last treatment]
Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy.
Other Outcome Measures
- SVR of ≥35% [Up to 24 Weeks]
Time to achievement of SVR of ≥35%
- Best response in SVR [At 24 Weeks]
Best response in SVR by MRI or CT scan
- >25% SVR [From baseline and at Week 24]
Proportion of patients achieving >25% SVR
- Red blood cell (RBC) [Baseline to End of Treatment]
Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24
- hemoglobin level [Weeks 12 and 24]
Improvement in hemoglobin level without transfusion at Weeks 12 and 24
- platelet count [Weeks 12 and 24]
Improvement in platelet count at Weeks 12 and 24
- platelet transfusions [Weeks 12 and 24]
Frequency of platelet transfusions at Weeks 12 and 24
- PROMIS [Baseline to Week 24]
Improvement in fatigue as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) v.1.0 - Fatigue from Baseline through Week 24
- Leukemia-free survival (LFS) [Baseline to Week 24]
Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy
- The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin [Baseline to 24 weeks]
The percentage of red blood cell transfusion-independent patients at baseline achieving a 1 g/dL and a 2 g/dL increase in hemoglobin at week 24
- The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia [Baseline to 24 weeks]
The percentage of platelet transfusion-independent patients at baseline with improvement in grade of thrombocytopenia at week 24
- The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate [Baseline to 24 weeks]
The percentage of transfusion-dependent patients at baseline achieving transfusion independence and achieving 50% reduction in transfusion rate at week 24
- Hemaglobin A1c [Baseline to Week 24]
Changes in hemoglobin A1c
- mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers [Baseline to up to 24 Weeks]
Changes in mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
- The proportion of patients who experience a major adverse cardiac event (MACE) [Baseline to up to 24 Weeks]
MACE is a composite endpoint that is considered to occur if any of the following TEAEs occur: cardiovascular death, defined as death due to acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, or death due to peripheral artery disease non-fatal myocardial infarction non-fatal stroke of any classification, including reversible focal neurological defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage
Eligibility Criteria
Criteria
Diagnosis and Inclusion Criteria
-
PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008)
-
Average platelet count of <50,000/µL at Screening (Day -35 to Day -3) based on two measurements taken on different days; both measurements must be <50,000/µL
-
DIPSS Intermediate-1, Intermediate-2, or High risk (Passamonti et al 2010)
-
Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
-
TSS of ≥10 on the MPN-SAF TSS 2.0 or a single symptom score of ≥5 or two symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats
-
If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria:
-
Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.
-
Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less. The 270-day period starts on the date of first ruxolitinib administration and continues for 270 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.The patient may not have received >10 mg of ruxolitinib on any day during that interval
-
Age ≥18 years
-
Eastern Cooperative Oncology Group performance status 0 to 2
-
Peripheral blast count of <10% throughout the Screening period and at baseline
-
Absolute neutrophil count of ≥500/µL
-
Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
-
Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN if transaminase elevation is related to MF), total bilirubin ≤4 x ULN (in cases where total bilirubin is elevated, direct bilirubin ≤4 × ULN, is required) and creatinine ≤2.5 mg/dL
-
Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN
-
If fertile, willing to use effective birth control methods during the study
-
Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
-
Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
-
Provision of signed informed consent
Exclusion Criteria
-
Life expectancy <6 months
-
Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allo-SCT
-
History of splenectomy or planning to undergo splenectomy
-
Splenic irradiation within the last 6 months
-
Previously treated with pacritinib
-
Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
-
Any prior treatment with more than one JAK2 inhibitor
-
Treatment with an experimental therapy within 28 days prior to treatment Day 1
-
Systemic treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
-
Significant recent bleeding history defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)
-
Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤100 mg per day), anti-vascular endothelial growth factor (anti-vascular endothelial growth factor [anti-VEGF]) agents, and daily use of cyclooxygenase-1 (COX-1) inhibiting nonsteroidal anti- inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1
-
Systemic treatment with medications that can prolong the QT interval within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
-
Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non- dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Medical Monitor, if stable and unlikely to affect patient safety.
-
Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the Medical Monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
-
QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome
-
New York Heart Association Class II, III, or IV congestive heart failure
-
Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
-
Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
-
Other malignancy within 3 years prior to treatment Day 1. The following patients may be eligible despite having had a malignancy within the prior 3 years: patients with curatively treated squamous or basal cell carcinoma of the skin; patients with curatively treated non-invasive cancers; patients with organ-confined prostate cancer with prostate-specific antigen (PSA) <20 ng/mL and National Comprehensive Cancer Network risk of Very Low, Low, or Favorable Intermediate; and patients with curatively treated non-metastatic prostate cancer with negative PSA.
-
Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
-
Known seropositivity for human immunodeficiency virus
-
Known active hepatitis A, B, or C virus infection
-
Women who are pregnant or lactating
-
Concurrent enrollment in another interventional trial
-
Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator
-
Known hypersensitivity to pacritinib or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate; any contraindication to the "physician's choice" medicinal product selected by the investigator to be used as the comparator or to loperamide or equivalent antidiarrheal medication.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
2 | Mayo Clinic Hospital | Phoenix | Arizona | United States | 85054 |
3 | City of Hope | Duarte | California | United States | 91010 |
4 | USC Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
5 | UCLA David Geffen School of Medicine | Los Angeles | California | United States | 90095 |
6 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
7 | Rocky Mountain Cancer Centers (US Oncology/McKesson) | Boulder | Colorado | United States | 80303 |
8 | Yale School of Medicine | New Haven | Connecticut | United States | 06510 |
9 | Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
10 | George Washington University-Medical Faculty Associates | Washington | District of Columbia | United States | 20037 |
11 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
12 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
13 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
14 | The University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
15 | University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | United States | 66205 |
16 | Ochsner Medical Center | New Orleans | Louisiana | United States | 70121 |
17 | Saint Agnes Hospital | Baltimore | Maryland | United States | 21229 |
18 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
19 | American Oncology Partners of Maryland, PA | Bethesda | Maryland | United States | 20817 |
20 | Regional Cancer Care Associates LLC - CCBD Division | Bethesda | Maryland | United States | 20817 |
21 | Maryland Oncology Hematology, PA- Columbia | Columbia | Maryland | United States | 21044 |
22 | Dana Farber Cancer Institute, Massachusetts General Hospital | Boston | Massachusetts | United States | 02215 |
23 | Michigan Medicine Hematology Clinic-Rogel Cancer Center | Ann Arbor | Michigan | United States | 48109 |
24 | Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | United States | 49546 |
25 | Washington University School of Medicine-Siteman Cancer Center | Saint Louis | Missouri | United States | 63110 |
26 | Comprehensive Cancer Centers of Nevada- Twain Office | Las Vegas | Nevada | United States | 89169 |
27 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
28 | Memorial Sloan-Kettering Cancer Center- Commack | Commack | New York | United States | 11725 |
29 | Columbia University Medical Center | New York | New York | United States | 10017 |
30 | Weill Cornell Medical College | New York | New York | United States | 10021 |
31 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
32 | Memorial Sloan -Kettering Cancer Center | New York | New York | United States | 10065 |
33 | University of Rochester | Rochester | New York | United States | 14642 |
34 | Duke University Hospital | Durham | North Carolina | United States | 27710 |
35 | Cleveland Clinic | Cleveland | Ohio | United States | 44106 |
36 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
37 | Oregon Health and Science University | Portland | Oregon | United States | 97239-3098 |
38 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
39 | The Sarah Cannon Research Institute-Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
40 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
41 | Mays Cancer Center | San Antonio | Texas | United States | 78229 |
42 | Texas Oncology- San Antonio | San Antonio | Texas | United States | 78240 |
43 | University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
44 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
45 | Westmead Hospital | Sydney | New South Wales | Australia | |
46 | Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service | Melbourne | Victoria | Australia | |
47 | The Perth Blood Institute | Perth | Western Australia | Australia | |
48 | Republican Research Center for Radiation Medicine and Human Ecology | Gomel | Belarus | ||
49 | Grodno University Hospital | Grodno | Belarus | ||
50 | Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology | Minsk | Belarus | ||
51 | University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" | Pleven | Bulgaria | ||
52 | University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv | Plovdiv | Bulgaria | ||
53 | Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy | Sofia | Bulgaria | ||
54 | Specialized Hospital for Active Treatment of Hematological Diseases | Sofia | Bulgaria | ||
55 | Multiprofile Hospital for Active Treatment "Sveta Marina" | Varna | Bulgaria | ||
56 | Tom Baker Cancer Center, Internal Medicine/Hematology | Calgary | Alberta | Canada | T2N 4N2 |
57 | University of Alberta | Edmonton | Alberta | Canada | T2N 4N2 |
58 | Providence Hematology - Vancouver | Vancouver | British Columbia | Canada | V6Z 2A5 |
59 | Eastern Regional Health Authority | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
60 | Nova Scotia Health Authority, Centre for Clinical Research | Halifax | Nova Scotia | Canada | B3H 2Y9 |
61 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
62 | Jewish General Hospital; Clinical Research Unit | Montreal | Quebec | Canada | H3T 1E2 |
63 | University Hospital Brno | Brno | Czechia | ||
64 | University Hospital Olomouc | Olomouc | Czechia | ||
65 | University Hospital Plzen | Pilsen | Czechia | ||
66 | University Hospital Kralovske Vinohrady, Clinic of Internal Hematology | Prague | Czechia | ||
67 | CHU Hôpital Amiens Sud | Amiens | France | 80054 | |
68 | CHU de Nimes - Hopital Universitaire Caremeau | Nîmes | France | 30900 | |
69 | Hôpital Saint-Louis | Paris | France | ||
70 | CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque | Pessac | France | 33604 | |
71 | Centre Hospitalier Lyon-Sud | Pierre Benite | France | ||
72 | University Hospital Center of Poitiers | Poitiers | France | ||
73 | Hautepierre Hospital | Strasbourg | France | ||
74 | Centre Hospitalier de Toulouse- Hôpital Purpan | Toulouse | France | ||
75 | JSC K. Eristavi National Center For Experimental and Clinical Surgery | Tbilisi | Georgia | ||
76 | LTD M.Zodelava's Hematology Center, Department of Hematology | Tbilisi | Georgia | ||
77 | LTD S.Khechinashvili University Hospital | Tbilisi | Georgia | ||
78 | Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD | Tbilisi | Georgia | ||
79 | University Hospital Cologne, Department of Internal Medicine I, | Cologne | Germany | ||
80 | University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology | Halle | Germany | ||
81 | Johannes Wesling Hospital Minden, Department of Oncology and Hematology | Minden | Germany | ||
82 | Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology | Munich | Germany | ||
83 | University Hospital Ulm, Center for Internal Medicine, | Ulm | Germany | ||
84 | Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika | Budapest | Hungary | ||
85 | University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ) | Debrecen | Hungary | ||
86 | Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | Hungary | ||
87 | Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine | Kecskemét | Hungary | ||
88 | Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology | Nyíregyháza | Hungary | ||
89 | Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I | Székesfehérvár | Hungary | ||
90 | Lady Davis Carmel Medical Center, Department of Hematology, | Haifa | Israel | ||
91 | Hadassah Medical Center, Department of Hematology, | Jerusalem | Israel | ||
92 | Meir Medical Center, Hematology Institute and Blood Bank | Kfar Saba | Israel | ||
93 | Rabin Medical Center, Clinic for Myeloproliferative Disorders | Petah-Tikva | Israel | ||
94 | The Tel Aviv Sourasky Medical Center, Department of Internal Medicine | Tel Aviv | Israel | ||
95 | Cancer Institute "Giovanni Paolo II", IRCCS | Bari | Italy | ||
96 | Polyclinic S. Orsola-Malpighi | Bologna | Italy | ||
97 | Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | ||
98 | Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS | Forlì | Italy | ||
99 | ASST Monza - Ospedale San Gerardo | Monza | Italy | ||
100 | United Hospitals Villa Sofia Cervello | Palermo | Italy | ||
101 | Polyclinic San Matteo, IRCCS | Pavia | Italy | ||
102 | Hospital "Infermi" of Rimini | Rimini | Italy | ||
103 | University Polyclinic Foundation "Agostino Gemelli" | Rome | Italy | ||
104 | ASST Sette Laghi Hospital | Varese | Italy | ||
105 | Pusan National University Hospital | Busan | Korea, Republic of | ||
106 | Kyungpook National University Hospital | Daegu | Korea, Republic of | ||
107 | Severance Hospital | Seoul | Korea, Republic of | 3722 | |
108 | Samsung Medical Center | Seoul | Korea, Republic of | ||
109 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
110 | The Catholic University of Korea, St. Mary's Hospital | Seoul | Korea, Republic of | ||
111 | University Clinical Center in Gdansk | Gdańsk | Poland | ||
112 | University Hospital in Krakow | Kraków | Poland | ||
113 | Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology, | Rzeszów | Poland | ||
114 | Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka | Toruń | Poland | ||
115 | Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology | Warsaw | Poland | ||
116 | Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation | Wrocław | Poland | ||
117 | Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz | Łódź | Poland | ||
118 | City Clinical Hospital #40 | Moscow | Russian Federation | ||
119 | City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health | Moscow | Russian Federation | ||
120 | S.P. Botkin City Clinical Hospital | Moscow | Russian Federation | ||
121 | Clinic UZI 4D, LLC | Pyatigorsk | Russian Federation | ||
122 | Research Institute of Hematology and Transfusiology | Saint Petersburg | Russian Federation | ||
123 | S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division | Saint Petersburg | Russian Federation | ||
124 | V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology | Saint Petersburg | Russian Federation | ||
125 | V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology | Samara | Russian Federation | ||
126 | Bashkiria State Medical University, Department of Internal Medicine | Ufa | Russian Federation | ||
127 | Volgograd Regional Clinical Oncology Center | Volgograd | Russian Federation | ||
128 | Clinical Center of Serbia, Clinic of Hematology | Belgrade | Serbia | ||
129 | Clinical Center of Vojvodina, Clinic of Hematology | Novi Sad | Serbia | ||
130 | Hospital del Mar | Barcelona, | Spain | ||
131 | Hospital Clínic de Barcelona | Barcelona | Spain | ||
132 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
133 | Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy | Murcia | Spain | ||
134 | Clínica Universidad de Navarra | Pamplona | Spain | ||
135 | University Clinical Hospital of Salamanca, Department of Hematology | Salamanca | Spain | ||
136 | University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology | Valencia | Spain | ||
137 | Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology | Cherkasy | Ukraine | ||
138 | City Clinical Hospital #4" under Dnipro City Council | Dnipro | Ukraine | ||
139 | Regional Clinical Hospital, Department of Hematology, | Ivano-Frankivs'k | Ukraine | ||
140 | Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology | Kharkiv | Ukraine | ||
141 | Kyiv City Clinical Hospital #9, Hematology Department #1 | Kyiv | Ukraine | ||
142 | Kyiv Regional Oncology Center, Department of Hematology, | Kyiv | Ukraine | ||
143 | Limited Liability Company "City Doctor" | Kyiv | Ukraine | ||
144 | Institute of Blood Pathology and Transfusion Medicine, Department of Hematology | Lviv | Ukraine | ||
145 | Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology | Poltava | Ukraine | ||
146 | Royal Hallamshire Hospital, Department of Hematology | Sheffield | South Yorkshire | United Kingdom | |
147 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0ZD | |
148 | Barts Health NHS Trust - The Royal London Hospital | London | United Kingdom | E1 2ES | |
149 | Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | London | United Kingdom | ||
150 | Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | United Kingdom | ||
151 | The Christie NHS Foundation Trust | Manchester | United Kingdom | ||
152 | Oxford University Hospitals NHS Trust - Churchill Hospital | Oxford | United Kingdom |
Sponsors and Collaborators
- CTI BioPharma
- PSI CRO
Investigators
- Study Director: Simran Bedi Singh, CTI BioPharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PAC203/PAC303
- PAC303