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Clinical Trial Finder

Search Results

A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis

Study Purpose

Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis. Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Phase 2 part: Patients with confirmed diagnosis of MF who meet all of the following criteria:
  • - ANC ≥ 1 x 10^9/L without the assistance of granulocyte growth factors.
  • - Peripheral blood blast count <10% - ECOG performance status ≤ 2.
  • - Adequate hematological, renal, hepatic, and coagulation laboratory assessments.
  • - No prior treatment with a BET inhibitor.
  • - Patients must give written informed consent to participate in this study before the performance of any study-related procedure.
For Arm 1 and 2 the following criteria should be considered:
  • - Patients with confirmed diagnosis of MF who meet all of the following criteria.
  • - Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-2 or higher.
  • - Spleen volume ≥ 450 cm^3 by MRI or CT for Cohorts 1B and 2B OR RBC transfusion dependent (defined as an average of ≥2 units of RBC transfusions per month over the 12 weeks prior to enrollment for Cohorts 1A and 2A) - At least 2 symptoms measurable (Score ≥ 1) using the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0) - Platelet count ≥ 75 x 10^9/L without the assistance of thrombopoietic factors or transfusions for at least 14 days.
Monotherapy Arm (Arm 1): Previously treated with a JAK inhibitor and be intolerant, resistant, refractory, or lost response to the JAK inhibitor; have not received the JAK inhibitor within 2 weeks prior to the start of study drug, or are ineligible to be treated with a JAK inhibitor. Combination Arm (Arm 2): Must have received single agent ruxolitinib and be on a stable dose for a minimum 8 weeks but have disease that is not being adequately controlled by ruxolitinib. For Arm 3 (JAK inhibitors naïve) the following criteria should be considered:
  • - Patients with confirmed diagnosis of MF who meet all of the following criteria.
  • - Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-2 or higher.
  • - Platelet count ≥ 100 x 10^9/L without the assistance of thrombopoietic factors or transfusions.
  • - Spleen volume ≥ 450 cm^3 by MRI/CT.
  • - At least 2 symptoms measurable (Score ≥ 3) or a total score of ≥ 10 using the MFSAF v4.0.
  • - No prior treatment with JAKi allowed.
For Arm 4 (ET Expansion) the following criteria should be considered:
  • - Patients with a confirmed diagnosis of ET.
  • - High-risk disease, defined as meeting at least one of the following criteria: - Age > 60 years.
  • - Platelet count > 1500 × 10^9/L (at any point during the patient's disease) - Previously documented thrombosis, erythromelalgia, or migraine.
  • - Previous hemorrhage related to ET.
  • - Diabetes or hypertension requiring pharmacological therapy for > 6 months.
  • - Have ≥2 symptoms with an average score ≥ 3 over the 7-day period prior to Cycle 1 Day 1 or an average total score of ≥15 over the 7-day period prior to Cycle 1 Day 1 using the using the MPN SAF.
  • - Platelets > 600 × 10^9/L.
  • - Resistant or intolerant to HU.

Exclusion Criteria:

  • - Current known active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
  • - Impaired cardiac function or clinically significant cardiac diseases.
  • - Patients with Child-Pugh Class B or C.
  • - Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of CPI-0610 and/or ruxolitinib, including any unresolved nausea, vomiting, or diarrhea that is CTCAE Grade >1.
  • - Prior treatment with a BET inhibitor.
  • - Pregnant or lactating women.
  • - Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study.
  • - Patients unwilling or unable to comply with this study protocol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02158858
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Constellation Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Belgium, Canada, France, Germany, Italy, Netherlands, Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis, Leukemia, Myelocytic, Acute, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic Syndrome (MDS), Preleukemia, Primary Myelofibrosis, Myeloproliferative Disorders, Bone Marrow Disease, Hematological Disease, Precancerous Conditions, Neoplasms, Leukemia, Neoplasms by Histologic Type, Essential Thrombocytosis
Arms & Interventions

Arms

Experimental: Arm 1: Prior JAKi (JAK inhibitor) Monotherapy Arm

Cohort 1A: Open to patients with MF who are Transfusion Dependent (TD) and who have previously been treated with a JAKi and are intolerant, resistant, refractory or lost response to the JAKi, or are ineligible to be treated with a JAKi.(CPI-0610 alone) Cohort 1B: Open to patients with MF who are not TD and who have previously been treated with a JAKi and are intolerant, resistant, refractory or lost response to the JAKi, or are ineligible to be treated with a JAKi. (CPI-0610 alone)

Experimental: Arm 2: Prior JAKi Combination Arm

Cohort 2A: Open to patients with MF who are Transfusion Dependent (TD) and are currently taking ruxolitinib but have disease that is not being adequately controlled by ruxolitinib. (CPI-0610 + Ruxolitinib) Cohort 2B: Open to patients with MF who are not TD and are currently taking ruxolitinib but have disease that is not being adequately controlled by ruxolitinib. (CPI-0610 + Ruxolitinib)

Experimental: Arm 3: JAKi Naïve Combination Arm

Open to patients with MF who have not previously received a JAKi. (CPI-0610 + Ruxolitinib) and have DIPSS risk category Intermediate-2 or higher

Experimental: Arm 4: Essential Thrombocythemia (ET) Monotherapy Arm

Open to high-risk patients with ET who are resistant or intolerant to hydroxyurea (HU)

Interventions

Drug: - CPI-0610

Drug: - Ruxolitinib

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic - Research Center, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic - Research Center

Phoenix, Arizona, 85054

Site Contact

Christine Reed-Pease

ReedPease.Christine@mayo.edu

480-342-6068

UCLA Medical Center, Los Angeles, California

Status

Recruiting

Address

UCLA Medical Center

Los Angeles, California, 90095

Site Contact

Farzam Hariri

FHariri@mednet.ucla.edu

+1 844 667-1992

Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic - Cancer Clinical Research Office

Jacksonville, Florida, 32224

Site Contact

Iwona Smusz

Smusz.Iwona@mayo.edu

904-953-2000

Chicago, Illinois

Status

Recruiting

Address

Northwestern University - Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611

Site Contact

Pyone Maung

pyone.maung@northwestern.edu

312-926-4828

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Christine Connolly

cconnolly1@partners.org

617-726-5131

University of Michigan Medical Center, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Medical Center

Ann Arbor, Michigan, 48109

Site Contact

D'Andra Featherstone

canceranswerline@med.umich.edu

800-865-1125

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicne Neuromuscular Division Department of neurology

Saint Louis, Missouri, 63110

Site Contact

Nicole Gaudin

nrgaudin@wustl.edu

314-747-7960

Memorial Sloan Kettering Monmounth, Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmounth

Middletown, New Jersey, 07748

Site Contact

Maddie Shukla

shuklam@mskcc.org

+1 844 667-1992

Memorial Sloan Kettering Bergen, Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Site Contact

Maddie Shukla

shuklam@mskcc.org

+1 844 667-1992

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, 11725

Site Contact

Maddie Shukla

shuklam@mskcc.org

+1 844 667-1992

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Michaela Dougherty

mikaela.dougherty@mssm.edu

212-241-8839

Columbia University Medical Centre, New York, New York

Status

Withdrawn

Address

Columbia University Medical Centre

New York, New York, 10032

Site Contact

medinfo@morphosys.com

+1 844 667-1992

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Site Contact

Maddie Shukla

shuklam@mskcc.org

+1 844 667-1992

New York, New York

Status

Recruiting

Address

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, 10065

Site Contact

Gabriela Hoberman

gah4002@med.cornell.edu

212-746-5269

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Romany Gergis

RGergis@mdanderson.org

713-792-9116

Froedtert & Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Jessica Guhl

jguhl@mcw.edu

414-805-0505

International Sites

ZNA Stuyvenberg Antwerpen, Antwerpen, Belgium

Status

Recruiting

Address

ZNA Stuyvenberg Antwerpen

Antwerpen, , 2060

Site Contact

Karen Cox

karen.cox@zna.be

(32 3) 217-7448

Brugge, Belgium

Status

Recruiting

Address

AZ Sint-Jan Burgge-Oostende - Campus Sint-Jan

Brugge, , 8000

Site Contact

Valerie Tanghe

Valerie.tanghe@azsintjan.be

(32 5) 045-3060

UZ Leuven - Campus Gasthuisberg, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven - Campus Gasthuisberg

Leuven, , 3000

Site Contact

Charlotte Tuerlinckx

charlotte.tuerlinckx@uzleuven.be

(32 1) 634-6880

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3

Site Contact

Ovais Shaikh

Ovais.Shaikh@albertahealthservices.ca

780-407-3365

St. Paul's Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2A5

Site Contact

Tathiana Ruiz

truiz1@providencehealth.bc.ca

604-682-2344

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Status

Recruiting

Address

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2

Site Contact

Debbie Valiquette

valiquette@HHSC.CA

905-389-4411 #64421

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Site Contact

Kylie Martin

Kylie.Martin@uhn.ca

416-946-4501 #4750

Jewish General Hospital, Montreal, Quebec, Canada

Status

Recruiting

Address

Jewish General Hospital

Montreal, Quebec, H3T 1E2

Site Contact

Chadi Zakaria

chadi.zakaria.ccomtl@ssss.gouv.qc.ca

514-340-8222 #28326

Lille, France

Status

Recruiting

Address

CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

Lille, , 59000

Site Contact

Florence Roge

florence.roge@chru-lille.fr

(33 3) 2044-4290

Nîmes, France

Status

Recruiting

Address

Institut de cancérologie du Gard - Hematologie clinique

Nîmes, , 30029

Site Contact

Maria Alessandra Damiano

MariaAlessandra.DAMIANO@chu-nimes.fr

(33 4) 6668-3528

Paris, France

Status

Recruiting

Address

CHU - Hopital Saint Louis - Centre D'Investigations Clinique

Paris, , 75010

Site Contact

Jin Huang

jin.huang-ext@aphp.fr

(33 01) 4238-5205

CHRU de Lille - Hopital Claude Huriez, Toulouse, France

Status

Recruiting

Address

CHRU de Lille - Hopital Claude Huriez

Toulouse, , 31100

Site Contact

Jeanne Francoise

jeanne.francoise@iuct-oncopole.fr

(33 5) 3115-6331

Institut Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Institut Gustave Roussy

Villejuif, , 94800

Site Contact

Laetitia Pireyre

laetitia.pireyre@gustaveroussy.fr

(33 1) 4211-4385

Jena, Germany

Status

Recruiting

Address

Universitätsklinikum Jena, Innere Medizin II

Jena, , 07747

Site Contact

Gitta Bienert

Gitta.Bienert@med.uni-jena.de

(49 3641) 932-4673

Universität zu Köln, Köln, Germany

Status

Recruiting

Address

Universität zu Köln

Köln, , 50937

Site Contact

Betül Özdemir

betuel.oezdemir@uk-koeln.de

(49 221) 4789-7050

Universitätsklinikum Leipzig AöR, Leipzig, Germany

Status

Recruiting

Address

Universitätsklinikum Leipzig AöR

Leipzig, , 04103

Site Contact

Karolin Hubert

Karolin.Hubert@medizin.uni-leipzig.de

(49 341) 971-3050

Bologna, Italy

Status

Recruiting

Address

Institue of Hematology "L. and A. Seràgnoli"

Bologna, , 40138

Site Contact

Federica Dambrosio

Federica.dambrosio3@unibo.it

(39 051) 214-4569

Firenze, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria Careggi

Firenze, , 50134

Site Contact

Chiara Paoli

Chiara.paoli@unifi.it

(39 055) 794-7331

Genova, Italy

Status

Recruiting

Address

AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

Genova, , 16132

Site Contact

Maria Grazia Ciardo

Ciardomg.82@gmail.com

(39 010) 555-3302

Genova, Italy

Status

Recruiting

Address

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Genova, , 16132

Site Contact

Adriana Carolei

a.carolei@smatteo.pv.it

(39 0382) 502-767

Milano, Italy

Status

Recruiting

Address

Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

Milano, , 20122

Site Contact

Silvia Artuso

silvia.artuso@policlinico.mi.it

(39 02) 5503-5420

AOU Maggiore della Carità, Novara, Italy

Status

Recruiting

Address

AOU Maggiore della Carità

Novara, , 28100

Site Contact

Clara Deambrogi

clara.deambrogi@med.uniupo.it

(39 032) 166-0655

Rimini, Italy

Status

Recruiting

Address

Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale (AUSL) di Rimini - Ospedale Infermi di Rimini

Rimini, , 47923

Site Contact

Dora Prota

Dora.prota@auslromagna.it

(39 0541) 705-866

Varese, Italy

Status

Recruiting

Address

Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon

Varese, , 21100

Site Contact

Alessia Ingrassia

alessia.ingrassia@asst-settelaghi.it

(39 033) 239-3904

Academisch Ziekenhuis Vrije Universiteit, Amsterdam, Netherlands

Status

Recruiting

Address

Academisch Ziekenhuis Vrije Universiteit

Amsterdam, , 1081 BT

Site Contact

Tineke Kruijt

j.kruijt@vumc.nl

(31 20) 444-4790

Maastricht University Medical Center, Maastricht, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center

Maastricht, , 6229 HX

Site Contact

Claudia Geesing

research.hematologie@mumc.nl

(31 43) 388-2901

Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Universitair Medisch Centrum Rotterdam

Rotterdam, , 3015 AA

Site Contact

Selina van Zelst

s.vanzelst@erasmusmc.nl

(31 10) 704-0704

Uniwersyteckie Centrum Kliniczne, Gdańsk, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne

Gdańsk, , 80-214

Site Contact

Agnieszka Religa

areliga@uck.gda.pl

(48 58) 349-2230

SPZOZ Szpital Uniwersytecki w Krakowie, Kraków, Poland

Status

Recruiting

Address

SPZOZ Szpital Uniwersytecki w Krakowie

Kraków, , 31-501

Site Contact

Sylwia Czekalska

sczekalska@gmail.com

(48 60) 674-9792

Warszawa, Poland

Status

Recruiting

Address

Instytut Hematologii i Transfuzjologii w Warszawie

Warszawa, , 02-776

Site Contact

Monika Jusko

mjusko@ihit.waw.pl

+1 844 667-1992

Belfast City Hospital, Belfast, United Kingdom

Status

Recruiting

Address

Belfast City Hospital

Belfast, , BT9 7AB

Site Contact

Joanne Todd

joanne.todd@belfasttrust.hscni.net

(44 289) 032-9241

University of Cambridge, Cambridge, United Kingdom

Status

Recruiting

Address

University of Cambridge

Cambridge, , CB2 0QQ

Site Contact

Thomas Jones

thomas.jones@addenbrookes.nhs.uk

(44 1223) 331-153

University Hospital of Wales, Cardiff, United Kingdom

Status

Recruiting

Address

University Hospital of Wales

Cardiff, , CF14 4XW

Site Contact

Marc Jones

marc.jones4@wales.nhs.uk

(44 29) 2073-6011

Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

Status

Recruiting

Address

Beatson West of Scotland Cancer Centre

Glasgow, , G12 0YN

Site Contact

Brodie Mckirdle

Brodie.mckirdle@glasgow.ac.uk

(44 141) 301-7000

Oxford University Hospitals, Headington, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals

Headington, , OX3 7LE

Site Contact

Rosie Lomas

rosie.lomas@oncology.ox.ac.uk

(44 1865) 235-234

Clatterbridge Cancer Centre, Liverpool, United Kingdom

Status

Recruiting

Address

Clatterbridge Cancer Centre

Liverpool, , L7 8XP

Site Contact

Laura Connolly

Laura.connolly3@nhs.net

(44 151) 334-1155

London, United Kingdom

Status

Recruiting

Address

University College London Hospital's NHS foundation Trust

London, , NW1 2BU

Site Contact

Faustine Laval

faustine.laval@nhs.net

(44 203) 447-7240

London, United Kingdom

Status

Recruiting

Address

Guys and St Thomas' Hospital - Haematology

London, , SE1 9RT

Site Contact

Esther Ale

Esther.ale@gstt.nhs.uk

(44 20) 7188-2739

The Christie Hospital, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital

Manchester, , M20 4BX

Site Contact

Ryan James Roberts

Ryanjames.roberts@christie.nhs.uk

(44 161) 918-2309

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