A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
Rekrutierend
NCT-Nummer:
NCT04576156
Studienbeginn:
April 2021
Letztes Update:
29.02.2024
Wirkstoff:
Imetelstat, Best Available Therapy (BAT)
Indikation (Clinical Trials):
Primary Myelofibrosis
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Geron Corporation
Collaborator:
-
Studienleiter
Faye Feller Study DirectorGeron Corporation
Kontakt
Vivian Rodolf, MD Kontakt: Phone: +1 (650) 473-7793 E-Mail: myf3001-info@Geron.com» Kontaktdaten anzeigen
Jennifer Riggs Kontakt: Phone: +1 (650) 473-7793 E-Mail: myf3001-info@Geron.com» Kontaktdaten anzeigen
Studienlocations (3 von 217)
Fayetteville United States La Jolla Long Beach Los Angeles San Diego Whittier Hartford New Haven Plantation Tampa Fort Wayne Goshen South Bend Louisville Rockville Springfield Omaha East Syracuse New York Durham Canton Columbus York Greenville Sioux Falls Watertown Houston Ogden Salt Lake City Tacoma Ciudad de Buenos Aires Argentina Rosario Córdoba St Leonards Australia Herston Hobart Richmond Wein Austria Linz Wels Edegem Belgium Haine-Saint-Paul Liege Gent Antwerpen Jette Fortaleza Brazil Goiânia Curitiba Porto Alegre Florianópolis São Paulo Pleven Bulgaria Plovdiv Sofia Pereira Colombia Antioquia Cali Floridablanca Odense Denmark Nimes Cedex 09 France Tours Paris Haute-Vienne Nantes Nice Avignon cedex Pierre-benite Loire Le Mans Bobigny Brest cedex Tbilisi Georgia Mannheim Baden-Württemberg Germany Tübingen Deutschland Dresden Sachsen Kempten Bayern Halle (Saale) Sachsen-Anhalt Leipzig Lübeck Budapest Hungary Nyíregyháza Székesfehérvár New Delhi India Surat Bangalore Bengaluru Gurgaon Bhubaneswar Kolkata Hyderabad Pune Ashdod Israel Ashkelon Rehovot Zerifin Nahariya Tel Aviv Jerusalem Beersheba Haifa Cona Italy Rozzano Orbassano Alessandria Bologna Catania Firenze Genova Meldola Milano Monza Napoli Ravenna Reggio Calabria Rimini Roma Torino Varese Vicenza Busan Korea, Republic of Daegu Goyang-Si Incheon Seoul Seongdong Pulau Pinang Malaysia Johor Bahru Kota Bharu Kuching Ampang Slupsk Poland Piła Skorzewo Biała Podlaska Katowice Braga Portugal Coimbra Lisboa Porto Moscow Russian Federation Novosibirsk Tula Omsk Saint Petersburg Saint-Petersburg Saratov Singapore Badalona Spain Sabadell Las Palmas de Gran Canaria Málaga Alzira Alicante Cáceres Girona Granada Madrid Salamanca Valencia Zaragoza Chiayi City Taiwan Taichung City Taipei Adapazarı Turkey Ankara Istanbul Izmir Yenisehir/Mersin Maidstone United Kingdom London Oxford
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III. sz. 1088 Budapest HungaryZurückgezogen » Google-Maps Dél-pesti Centrumkórház Ország H-1097 Budapest HungaryRekrutierend » Google-Maps Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András 4400 Nyíregyháza HungaryRekrutierend » Google-Maps Fejer Megyei Szent Gyorgy Egye 8000 Székesfehérvár HungaryRekrutierend » Google-Maps All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences) 110029 New Delhi IndiaSchwebend » Google-Maps Sir Ganga Ram Hospital 110060 New Delhi IndiaRekrutierend » Google-Maps Nirmal Hospital - Hematology 395002 Surat IndiaRekrutierend » Google-Maps St. John's Medical College Hospital 560 034 Bangalore IndiaRekrutierend » Google-Maps Fortis Hospital 154/9 560076 Bengaluru IndiaRekrutierend » Google-Maps Fortis Memorial Research Institute 122002 Gurgaon IndiaRekrutierend » Google-Maps All India Institute of Medical Sciences 751019 Bhubaneswar IndiaRekrutierend » Google-Maps Nilratan Sircar Medical College 700014 Kolkata IndiaSchwebend » Google-Maps Narayana Hrudayalaya Hospital 560099 Hyderabad IndiaRekrutierend » Google-Maps Deenanath Mangeshkar Hospital & Research Center 411004 Pune IndiaRekrutierend » Google-Maps Sahyadri Specialty Hospital Pune IndiaRekrutierend » Google-Maps Assuta Ashdod University Hospi 7747629 Ashdod IsraelRekrutierend » Google-Maps Barzilai Medical Center 78278 Ashkelon IsraelRekrutierend » Google-Maps Kaplan Medical Center 7610001 Rehovot IsraelRekrutierend » Google-Maps Shamir Medical Center (Assaf Harofeh) 7030000 Zerifin IsraelRekrutierend » Google-Maps Western Galilee Hospital - Nahariya 22100 Nahariya IsraelRekrutierend » Google-Maps Tel Aviv Sourasky Medical Cent 49372 Tel Aviv IsraelZurückgezogen » Google-Maps Hadassah Medical Organization 9112001 Jerusalem IsraelRekrutierend » Google-Maps Soroka Medical Center - Hematology Institute 84101 Beersheba IsraelNoch nicht rekrutierend » Google-Maps Bnai Zion Medical Center 31048 Haifa IsraelRekrutierend » Google-Maps Carmel MC 3436212 Haifa IsraelRekrutierend » Google-Maps Arcispedale S.Anna - Ematologi 44124 Cona ItalyRekrutierend » Google-Maps Istituto Clinico Humanitas Roz 20089 Rozzano ItalyRekrutierend » Google-Maps AOU San Luigi Gonzaga 10043 Orbassano ItalyRekrutierend » Google-Maps PO Civile SS.Antonio e Biagio 15121 Alessandria ItalyRekrutierend » Google-Maps A.O.di Bologna Policl.S.Orsola 40138 Bologna ItalyRekrutierend » Google-Maps Presidio Ospedaliero Garibaldi 95122 Catania ItalyRekrutierend » Google-Maps AOU Careggi 50134 Firenze ItalyRekrutierend » Google-Maps IRCCS Ospedale Policlinico San Martino 16132 Genova ItalyNoch nicht rekrutierend » Google-Maps Clinica Ematologica, Univ. Deg 6- 16132 Genova ItalyRekrutierend » Google-Maps Irccs Irst 47014 Meldola ItalyRekrutierend » Google-Maps Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 20122 Milano ItalyNoch nicht rekrutierend » Google-Maps Ospedale San Raffaele 20132 Milano ItalyRekrutierend » Google-Maps ASST Grande Ospedale Metropoli 20162 Milano ItalyRekrutierend » Google-Maps Azienda Ospedaliera San Gerard 20900 Monza ItalyRekrutierend » Google-Maps AOU Federico II 80122 Napoli ItalyRekrutierend » Google-Maps Ospedale Civile S.Maria delle 48121 Ravenna ItalyRekrutierend » Google-Maps Arcispedale S Maria Nuova, AO di Reggio Emilia 42123 Reggio Calabria ItalyRekrutierend » Google-Maps Azienda Ospedaliera Bianchi-Me 89124 Reggio Calabria ItalyRekrutierend » Google-Maps AUSL di Rimini Ospedale Inferm 47900 Rimini ItalyRekrutierend » Google-Maps ASL Roma 2 - PO "S. 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Detailed Description: This is a multicenter study with 2 arms, and will include 3 phases: a) screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment, and the participant's eligibility will be reviewed; b) treatment phase, from randomization until study treatment (imetelstat or BAT) discontinuation; and c) post treatment follow-up phase, that begins when the participant discontinues treatment, and will continue until death, lost to follow-up, withdrawal of consent, or study end, whichever occurs first. Participants will be randomized (2:1) into 2 Arms (Arm A will receive imetelstat and Arm B will receive BAT). Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval.
Inclusion Criteria: - Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF according to the IWG-MRT criteria - Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF - Relapsed/refractory to JAK-inhibitor treatment as defined in either inclusion (i), (ii) or (iii) and not eligible for allogeneic stem cell transplantation (ASCT) at screening: - (i) Treatment with JAK-inhibitor for >= 6 months duration, including at least 2 months at an optimal dose as assessed by the investigator for that participant and at least one of the following: 1. no decrease in spleen volume (< 10% by MRI or CT) from the start of treatment with JAK-inhibitor 2. no decrease in spleen size (< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor 3. no decrease in symptoms (< 20% by Myelofibrosis Symptom Assessment Form [MFSAF] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor 4. a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening. - (ii) Treatment with JAK-inhibitor treatment for>= 3 months duration with maximal doses (e.g., 20-25 mg twice daily ruxolitinib) for that participant and no decrease in spleen volume/size or symptoms as defined in inclusion criterion (i [a, b, or c]). - (iii) Following maximum tolerated doses of JAK inhibitor therapy for ≥3 months duration, having documented relapsed disease defined as either 1. Increase in spleen volume from time of best response by 25% measured by MRI or CT, or 2. Increase in spleen size by palpation, CT, or ultrasound - (b.i) For splenomegaly of 5-10 cm at the start of JAK inhibitor treatment, at least 100% increase in palpable spleen size from time of best response; - (b.ii) For splenomegaly of > 10 cm at the start of JAK inhibitor treatment, at least 50% increase in palpable spleen size from time of best response; AND not a candidate for further JAK inhibitor at screening per investigator. - Measurable splenomegaly demonstrated by a palpable spleen measuring >= 5 cm below the left costal margin or a spleen volume >= 450 cm^3 by MRI or CT - Active symptoms of MF on the MFSAF v4.0 demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale) - Hematology laboratory test values within the protocol defined limits - Biochemical laboratory test values must be within protocol defined limits - Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2 - Participants should follow protocol defined contraceptives procedures - A woman of childbearing potential must have a negative serum or urine pregnancy test at screeningExclusion Criteria: - Peripheral blood blast count of >= 10% or bone marrow blast count of >=10% - Known allergies, hypersensitivity, or intolerance to imetelstat or its excipients - Prior treatment with imetelstat - Any chemotherapy or MF directed therapy, including investigational drug regardless of class or mechanism of action, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 mg/day prednisone or equivalent, and JAK-inhibitor treatment less than equal to 14 days prior to randomization - Diagnosis or treatment for malignancy other than MF except: - Malignancy treated with curative intent and with no known active disease present for >= 3 years before randomization - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated cervical carcinoma in situ without evidence of disease - Known history of human immunodeficiency virus or any uncontrolled active systemic infection requiring IV antibiotics - Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or any known acute or chronic liver disease requiring treatment unless related to underlying hepatosplenomegaly due to MF - Major surgery within 28 days prior to randomization - Any life-threatening illness (e.g., coronavirus disease-2019), medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk
Primary outcome: 1. Overall survival (OS) (Time Frame - Baseline (Day 1) until End of Study (EOS) (approximately 3 years )]):Overall survival is defined as the time interval from randomization date to date of death from any cause. Secondary outcome: 1. Symptom response rate (Time Frame - Baseline (Day 1), and at Week 24):The proportion of participants achieving a ≥50% reduction in Total Symptom Score (TSS) measured at Week 24 compared to baseline 2. Progression-free survival (Time Frame - Baseline (Day 1) until End of Study (EOS) (approximately 3 years)):Progression-free survival is defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria) or death from any cause, whichever occurs first. 3. Spleen response rate (Time Frame - Baseline (Day 1), and at Week 24):The proportion of participants who achieve a reduction in spleen volume of ≥ 35% from baseline at Week 24. 4. Complete remission (CR), partial remission (PR), clinical improvement (CI), spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria (Time Frame - Baseline (Day 1) until End of Treatment (approximately 3 years)):The proportion of participants achieving CR or PR, CI, spleen response, symptom response, and anemia response per modified 2013 IWG-MRT criteria. 5. Reduction in the degree of bone marrow fibrosis (Time Frame - Baseline (Day 1) until End of Treatment (approximately 3 years)):Reduction in the degree of bone marrow fibrosis will be assessed. 6. Number of Participants with Adverse Events (Time Frame - Screening (Day -28 to -1) until End of Study (approximately 3 years)):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 7. Assessment of Cmax (Time Frame - Day 1 of all cycles (each cycle is 21 days)):Maximum Observed Plasma Concentration (Cmax). 8. Assessment of Tmax (Time Frame - Day 1 of all cycles (each cycle is 21 days)):Time to reach the maximum observed plasma concentration 9. Assessment of t1/2 (Time Frame - Day 1 of all cycles (each cycle is 21 days)):Elimination half-life. 10. Assessment of AUC (Time Frame - Day 1 of all cycles (each cycle is 21 days)):Area under the drug concentration-plasma time curve (AUC) from time zero to last measurable concentration 11. European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores (Time Frame - Baseline to End of Study (approximately 3 years)):Patient-reported outcomes including health-related quality of life, pain, and overall change in participant's health will be assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are transformed to a 0 to 100 scale. Higher scores indicated worse outcome. 12. EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores (Time Frame - Baseline to End of Study (approximately 3 years)):EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Experimental: ImetelstatParticipants will receive imetelstat at 9.4 mg/kg intravenous (IV) every 21 days (±3 days), until disease progression or unacceptable toxicity, treatment discontinuation or study end. Active Comparator: Best Available Therapy (BAT)Participants will receive BAT (investigator-selected non-JAK-inhibitor treatment), until disease progression or unacceptable toxicity, treatment discontinuation or study end.
Participants on BAT who meet protocol-defined criteria for progressive disease may crossover to receive imetelstat treatment after sponsor's approval.
Imetelstat (GRN163L):Imetelstat will be given intravenously at 9.4 mg/kg every 21 days, until disease progression or unacceptable toxicity, treatment discontinuation or study end. Best Available Therapy (BAT):Non-JAK-inhibitor treatment will be given, which may include but is not limited to hydroxyurea, thalidomide or an analog of thalidomide, interferon, danazol, hypomethylating agents, chemotherapy or radiotherapy.
Quelle: ClinicalTrials.gov
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"A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment"
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