PACIFICA: A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Sponsor
CTI BioPharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03165734
Collaborator
PSI CRO (Industry)
399
152
2
102.2
2.6
0

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

Study Type:
Interventional
Anticipated Enrollment :
399 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)
Actual Study Start Date :
Jun 26, 2017
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

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:
  • corticosteroids
  • hydroxyurea
  • danazol
  • low-dose ruxolitinib
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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

    2. 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

    3. 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

    1. SVR of ≥35% [Up to 24 Weeks]

      Time to achievement of SVR of ≥35%

    2. Best response in SVR [At 24 Weeks]

      Best response in SVR by MRI or CT scan

    3. >25% SVR [From baseline and at Week 24]

      Proportion of patients achieving >25% SVR

    4. Red blood cell (RBC) [Baseline to End of Treatment]

      Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24

    5. hemoglobin level [Weeks 12 and 24]

      Improvement in hemoglobin level without transfusion at Weeks 12 and 24

    6. platelet count [Weeks 12 and 24]

      Improvement in platelet count at Weeks 12 and 24

    7. platelet transfusions [Weeks 12 and 24]

      Frequency of platelet transfusions at Weeks 12 and 24

    8. 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

    9. Leukemia-free survival (LFS) [Baseline to Week 24]

      Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy

    10. 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

    11. 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

    12. 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

    13. Hemaglobin A1c [Baseline to Week 24]

      Changes in hemoglobin A1c

    14. 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

    15. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Diagnosis and Inclusion Criteria

    1. PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008)

    2. 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

    3. DIPSS Intermediate-1, Intermediate-2, or High risk (Passamonti et al 2010)

    4. Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination

    5. 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

    6. If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria:

    7. 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.

    8. 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

    9. Age ≥18 years

    10. Eastern Cooperative Oncology Group performance status 0 to 2

    11. Peripheral blast count of <10% throughout the Screening period and at baseline

    12. Absolute neutrophil count of ≥500/µL

    13. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan

    14. 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

    15. Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN

    16. If fertile, willing to use effective birth control methods during the study

    17. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study

    18. Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument

    19. Provision of signed informed consent

    Exclusion Criteria

    1. Life expectancy <6 months

    2. Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allo-SCT

    3. History of splenectomy or planning to undergo splenectomy

    4. Splenic irradiation within the last 6 months

    5. Previously treated with pacritinib

    6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1

    7. Any prior treatment with more than one JAK2 inhibitor

    8. Treatment with an experimental therapy within 28 days prior to treatment Day 1

    9. 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

    10. 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)

    11. 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

    12. 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

    13. 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.

    14. 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.

    15. 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

    16. New York Heart Association Class II, III, or IV congestive heart failure

    17. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication

    18. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation

    19. 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.

    20. 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

    21. Known seropositivity for human immunodeficiency virus

    22. Known active hepatitis A, B, or C virus infection

    23. Women who are pregnant or lactating

    24. Concurrent enrollment in another interventional trial

    25. Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator

    26. 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.
    Responsible Party:
    CTI BioPharma
    ClinicalTrials.gov Identifier:
    NCT03165734
    Other Study ID Numbers:
    • PAC203/PAC303
    • PAC303
    First Posted:
    May 24, 2017
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CTI BioPharma
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022