Myeloproliferative Neoplasms Clinical Trial

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

Summary

The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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:

no decrease in spleen volume (< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
no decrease in spleen size (< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
no decrease in symptoms (< 20% by Myelofibrosis Symptom Assessment Form [MFSAF] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor

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

Increase in spleen volume from time of best response by 25% measured by MRI or CT, or
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 screening

Exclusion 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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

320

Study ID:

NCT04576156

Recruitment Status:

Recruiting

Sponsor:

Geron Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 160 Locations for this study

See Locations Near You

University of California-San Diego/Moores UCSD Cancer Center
La Jolla California, 92093, United States
UCLA david geffen school of medicine
Los Angeles California, 90096, United States
BRCR Medical Center Inc
Plantation Florida, 33326, United States
University of South Florida
Tampa Florida, 33612, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Prairie Lakes Health Care System, Inc.
Watertown South Dakota, 57201, United States
The University of Texas MD
Houston Texas, 77030, United States
Northwest Medical Specialties PLLC
Tacoma Washington, 98405, United States
Hospital Aleman
Ciudad de Buenos Aires Buenos Aires, C118A, Argentina
Clínica Los Arroyos
Rosario Santa Fe, 2000, Argentina
Sanatorio de la Mujer
Rosario Santa Fe, S2000, Argentina
Sanatorio Allende
Córdoba , X5000, Argentina
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Epworth Healthcare
Richmond Victoria, 3121, Australia
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Wein Burgenland, 1130, Austria
Krankenhaus der Elisabethinen
Linz Oberösterreich, 4020, Austria
UZ Antwerpen
Edegem Antwerpen, 2650, Belgium
Centre Hospitalier de Jolimont
Haine-Saint-Paul Hainaut, 7100, Belgium
Universitair Ziekenhuis Gent
Gent Oost-Vlaanderen, 9000, Belgium
Zna - Campus Middelheim
Antwerpen , 2020, Belgium
ZNA Stuyvenberg Antwerpen
Antwerpen , 2610, Belgium
AZ Klina
Antwerpen , 2930, Belgium
Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)
Jette , , Belgium
Centro de oncologia Leonardo da Vinci
Fortaleza Ceará, 60135, Brazil
Hospital das Clínicas UFG
Goiânia Goiás, 74605, Brazil
Hospital Erasto Gaertner
Curitiba Paraná, 81520, Brazil
Hospital de Clinicas de Porto Alegre - UFRGS
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA
Porto Alegre Rio Grande Do Sul, 90470, Brazil
CEPON Centro de Pesquisas Oncologicas SC
Florianópolis , 88034, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
São Paulo , 01323, Brazil
Hospital Israelita Albert Einstein
São Paulo , 05651, Brazil
Hospital A.C.Camargo Cancer Center - Clinical Oncology
São Paulo , , Brazil
UMHAT "Dr. Georgi Stranski"
Pleven , , Bulgaria
UMBAL Sveti Georgi
Plovdiv , 4002, Bulgaria
Specialized Hospital for Active Therapy of Hematological dis
Sofia , 1756, Bulgaria
Oncologos del Occidente S.A
Pereira Risaralda, 66000, Colombia
Hospital Pablo Tobon Uribe
Antioquia , , Colombia
Centro Medico Imbanaco de Cali S.A.
Cali , 42007, Colombia
FOSCAL
Floridablanca , , Colombia
Aarhus University Hospital - Hematology
Aarhus , 8200, Denmark
Odense University Hospital - Hematology
Odense , DK-50, Denmark
Institut de cancérologie du Gard - Hematologie clinique
Nimes Cedex 09 Gard, 30029, France
CHU Bretonneau
Tours Indre-et-Loire, 37044, France
CHU De Nantes - Hématologie C
Nantes Loire-Atlantique, 44093, France
Hospital CENTRE HOSPITALIER AVIGNON
Avignon cedex Provence-Alpes-Côte-d'Azur, 84902, France
Centre Hospitalier Lyon
Pierre-benite Rhône-Alpes, 69310, France
Centre Hospitalier Du Mans - Cancérologie Médicale
Le Mans Sarthe, 72037, France
Hopital Avicenne - Hématologie Clinique
Bobigny Seine-Saint-Denis, 93009, France
CHRU Brest - Hôpital Morvan
Brest cedex , 29609, France
CHU - Hôpital Saint Louis - Centre D'Investigations Cliniq
Paris , 75010, France
Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre
Paris Île-de-France, 75679, France
LTD Israeli-Georgian Medical R
Tbilisi , 0112, Georgia
M.Zodelava Hematology Center L
Tbilisi , 0112, Georgia
J.S.C."K.Eristavi National Cen
Tbilisi , 0159, Georgia
Multi Profile Clinic Consilium
Tbilisi , 0179, Georgia
Ltd "Medinvest" Institute of H
Tbilisi , 186, Georgia
Universitätsklinikum Tübingen
Tübingen Baden-Württemberg, 72076, Germany
Universitätsklinikum Carl Gust
Dresden Hamburg, 1307, Germany
Klinikum Kempten-Oberallgaeu GmbH
Kempten Rheinland-Pfalz, 87439, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle (Saale) Sachsen-Anhalt, 6120, Germany
Universitätsklinikum Leipzig AöR
Leipzig Sachsen, 04103, Germany
Universitätsklinikum Schleswig
Kiel Schleswig-Holstein, 24105, Germany
Semmelweis Egyetem - III. sz.
Budapest , 1088, Hungary
Dél-pesti Centrumkórház Ország
Budapest , H-109, Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András
Nyíregyháza , 4400, Hungary
Fejer Megyei Szent Gyorgy Egye
Székesfehérvár , 8000, Hungary
All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)
New Delhi Delhi, 11002, India
Sir Ganga Ram Hospital
New Delhi Delhi, 11006, India
Nirmal Hospital - Hematology
Surat Gujarat, 39500, India
St. John's Medical College Hospital
Bangalore Karnataka, 560 0, India
Fortis Hospital 154/9
Bengaluru Karnataka, 56007, India
Fortis Memorial Research Institute
Gurgaon New Delhi, 12200, India
All India Institute of Medical Sciences
Bhubaneswar Orissa, 75101, India
Nilratan Sircar Medical College
Kolkata West Bengal, 70001, India
Narayana Hrudayalaya Hospital
Hyderabad , 56009, India
Deenanath Mangeshkar Hospital & Research Center
Pune , 41100, India
Sahyadri Specialty Hospital
Pune , , India
Assuta Ashdod University Hospi
Ashdod HaDarom, 77476, Israel
Barzilai Medical Center
Ashkelon HaDarom, 78278, Israel
Kaplan Medical Center
Rehovot HaMerkaz, 76100, Israel
Shamir Medical Center (Assaf Harofeh)
Zerifin HaMerkaz, 70300, Israel
Western Galilee Hospital - Nahariya
Nahariya HaZafon, 22100, Israel
Tel Aviv Sourasky Medical Cent
Tel Aviv Tel-Aviv, 49372, Israel
Hadassah Medical Organization
Jerusalem Yerushalayim, 91120, Israel
Bnai Zion Medical Center
Haifa , 31048, Israel
Carmel MC
Haifa , 34362, Israel
Arcispedale S.Anna - Ematologi
Cona Ferrara, 44124, Italy
Istituto Clinico Humanitas Roz
Rozzano Milano, 20089, Italy
AOU San Luigi Gonzaga
Orbassano Torino, 10043, Italy
PO Civile SS.Antonio e Biagio
Alessandria , 15121, Italy
A.O.di Bologna Policl.S.Orsola
Bologna , 40138, Italy
Presidio Ospedaliero Garibaldi
Catania , 95122, Italy
AOU Careggi
Firenze , 50134, Italy
Clinica Ematologica, Univ. Deg
Genova , 6- 16, Italy
Irccs Irst
Meldola , 47014, Italy
Ospedale San Raffaele
Milano , 20132, Italy
ASST Grande Ospedale Metropoli
Milano , 20162, Italy
Azienda Ospedaliera San Gerard
Monza , 20900, Italy
AOU Federico II
Napoli , 80122, Italy
Ospedale Civile S.Maria delle
Ravenna , 48121, Italy
Arcispedale S Maria Nuova, AO di Reggio Emilia
Reggio Calabria , 42123, Italy
Azienda Ospedaliera Bianchi-Me
Reggio Calabria , 89124, Italy
AUSL di Rimini Ospedale Inferm
Rimini , 47900, Italy
ASL Roma 2 - PO "S. Eugenio"
Roma , 00144, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Ospedale S.Bortolo, AULSS n.6
Vicenza , 36100, Italy
Kyungpook National University
Daegu Daegu Gwang'yeogsi [Taegu-Kwan], 41944, Korea, Republic of
Seoul National University Hospital - Department of Internal
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 03080, Korea, Republic of
Pusan National University Hospital - Hematology and Oncology
Busan , 49241, Korea, Republic of
The Catholic University of Korea
Seongdong , 6591, Korea, Republic of
Severance Hospital, Yonsei Uni
Seoul , 3722, Korea, Republic of
Hospital Pulau Pinang
Pulau Pinang Georgetown, 10990, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu Kelantan, 15586, Malaysia
Sarawak General Hospital
Kuching Sarawak, 93586, Malaysia
Hospital Ampang
Ampang Selangor, 68000, Malaysia
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl
Slupsk Pomorskie, 76-20, Poland
Ars Medical Sp. z o.o.
Piła Wielkopolskie, 64-92, Poland
Centrum Medyczne Pratia Poznan
Skorzewo Wielkopolskie, 60-18, Poland
Pratia Onkologia Katowice
Katowice Śląskie, 40-51, Poland
CCA-Braga. Centro Clínico Académico - Hospital Braga
Braga , 4710-, Portugal
CHUC - Centro Hospitalar e Uni
Coimbra , 3000-, Portugal
Instituto Português de Oncologia de Lisboa
Lisboa , 1099-, Portugal
Centro Clinico Fundacao Champalimaud
Lisboa , 1400-, Portugal
H. São Francisco Xavier-Centro
Lisboa , 1495-, Portugal
H. Santa Maria. Centro Hospita
Lisboa , 1649-, Portugal
MONIKI - Oncology
Moscow Moskovskaya Oblast', 12911, Russian Federation
Novosibirsk State Medical Univ
Novosibirsk Novosibirskaya Oblast', 63009, Russian Federation
GOU VPO Saratov State Medical University n.a. V.I. Razumovsk
Saratov Saratovskaya Oblast', 41001, Russian Federation
Tula Regional Clinical Hospital
Tula Tul'skaya Oblast', 30005, Russian Federation
Clinical oncological dispensar
Omsk , 64401, Russian Federation
FGU "Russian Research Institute
Saint Petersburg , 19102, Russian Federation
Saint-Petersburg State Medical
Saint Petersburg , 19702, Russian Federation
V.A. Almazov National Medical
Saint-Petersburg , 19734, Russian Federation
National University Cancer Institute (NCIS)
Singapore Central Singapore, 11907, Singapore
Singapore General Hospital
Singapore Central Singapore, 16960, Singapore
Institut Català d'Oncologia-Ho
Badalona Barcelona, 08916, Spain
C.S. Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitario de Gran
Las Palmas de Gran Canaria Canarias, 35019, Spain
H.U. Ribera de Alzira
Alzira Valencia, 46600, Spain
H.G.U. Alicante
Alicante , 03010, Spain
H. San Pedro de Alcántara
Cáceres , 10003, Spain
ICO-Hospital Universitari de G
Girona , 17007, Spain
Hospital Universitario Virgen
Granada , 18014, Spain
Hospital Universitario Fundaci
Madrid , 28040, Spain
Hospital U. 12 Octubre
Madrid , 28041, Spain
H.U. La Paz
Madrid , 28046, Spain
H.U.V. de la Victoria
Málaga , 29010, Spain
Complejo Asistencial Universit
Salamanca , 37007, Spain
Hospital Universitario Doctor
Valencia , 46017, Spain
H. Quirón Zaragoza
Zaragoza , 50012, Spain
Universitaetsspital Zuerich
Zurich , 8091, Switzerland
Chang Gung Medical Foundation
Chiayi City Chiayi, 613, Taiwan
China Medical University Hospital
Taichung City , 404, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
Ankara University Medical Facu
Ankara , 6590, Turkey
Istanbul Üniversitesi Cerrahpaşa
Istanbul , 34098, Turkey
Marmara university pendik training and research hospital
Istanbul , 34899, Turkey
Ege Universitesi Tip Fakultesi
Izmir , 35100, Turkey
Maidstone Hospital
Maidstone Kent, ME16 , United Kingdom
St Bartholomew's Hospital
London , EC1A , United Kingdom
Guys and St Thomas' Hospital
London , SE1 9, United Kingdom
Oxford University Hospitals
Oxford , OX3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

320

Study ID:

NCT04576156

Recruitment Status:

Recruiting

Sponsor:


Geron Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.