• Have any questions?
  • info@mpncancerconnection.org
Screen Shot 2016-03-16 at 5.15.52 PMScreen Shot 2016-03-16 at 5.15.52 PMScreen Shot 2016-03-16 at 5.15.52 PMScreen Shot 2016-03-16 at 5.15.52 PM
  • Our Mission
  • About
    • Our team
    • Info
    • David Wallace BioDavid Wallace - MPN Patient Advocate

      David Wallace

      Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate

      When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter,
      a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
      • Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
      • Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
      • Recipient of MPN Hero Award 2016
      • Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
      • Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
      • Awarded Press Credentials for American Society of Hematology Conference 2014-2019
      • Contributor to Patient Power MPN educational videos
      David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
  • Resources
    • Partners
    • Corporate Sponsors
    • Groups
  • Our Vision
  • Donate
  • Blog
  • Contact
  • Terms
  • Privacy
  • Partners
  • About
  • Contact
Donate

Clinical Trial Finder

Clinical Trial Finder

Search Results

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Study Purpose

The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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:

  • - Subjects must be ≥ 18 years at the time of signing the Informed Consent Form (ICF).
  • - Understanding and voluntary signing an IRB-approved informed consent form.
  • - Diagnosis of: 1.
Accelerated-phase (≥ 10% blasts in PB or BM) or blast-phase (≥ 20% blasts in PB or BM) myeloproliferative neoplasm (with history of prior myelofibrosis, polycythemia vera, or essential thrombocythemia) 2. Previously treated patients with myelofibrosis with persistent disease or progressive disease (persistent or progressive splenomegaly, leukocytosis, anemia, or thrombocytopenia) with intermediate-1 or greater risk disease according to 2013 International Working Group (IWG) criteria, and 4-9% circulating blasts.
  • - Demonstration of an IDH2 mutation.
  • - Platelet count > 75,000 X 109/L for chronic phase myelofibrosis patients.
  • - Prior therapy with either ruxolitinib or enasidenib is permitted, but not a combination of ruxolitinib and enasidenib.
  • - Patients with chronic phase myelofibrosis on ruxolitinib must be on the drug for at least 3 months and on a stable dose for at least one month.
  • - Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
ECOG 3 status will be allowed if attributable to MPN.
  • - Patients must have adequate organ function as demonstrated by the following: a.
Direct bilirubin < 2.0mg/dL, unless due to Gilbert's disease or current elevations in direct bilirubin associated with existing enasidenib use. b. Serum creatinine< 2.0 mg/dL. c. ALT and AST ≤ 3x upper limit of normal (unless transaminitis is considered to be related to MF).
  • - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to starting enasidenib and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking enasidenib.
FCBP must also agree to ongoing pregnancy testing. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • - All study participants must be able to swallow oral medication.
  • - Ability to adhere to the study visit schedule and all protocol requirements.

EXCLUSION CRITERIA:

  • - Use of any other standard anti-neoplastic drug or growth factor (e.g., anagrelide, G-CSF, lenalidomide, thalidomide clofarabine) except hydroxyurea or experimental drugs, with the exception of ruxolitinib or enasidenib, less than 14 days or 5-half-lives, whichever is longer, prior to starting study therapy and/or lack of recovery from all toxicity (except for alopecia) from previous therapy to Grade 1 or better.
a. Patients will be permitted to receive hydroxyurea while on study for up to a total of 3 cycles of combined therapy.
  • - Known prior clinically relevant hypersensitivity reaction to ruxolitinib or enasidenib.
  • - Prior therapy with enasidenib in combination with ruxolitinib.
  • - Concurrent use of strong inducers of CYP3A4 (Rifampin, St. John's Wort, Carbamazepine, Phenytoin) and/or the following strong inhibitors of CYP3A4 (protease inhibitor containing HIV anti-retrovirals, cobicistat, clarithromycin, itraconazole, ketoconazole, nefazodone, and telithromycin) are prohibited.
Also prohibited are CYP2C9 substrate medications that have a narrow therapeutic range: phenytoin and warfarin.
  • - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the study.
  • - Lactating females.
  • - Active uncontrolled infections.
  • - Patients with active malignancy of other type than required for this study are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
  • - Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment.
  • - QTc interval (Fridericia's correction [QTcF]) > 450 ms.
All inclusion and exclusion criteria will be reviewed by the Investigator or qualified designee to ensure that the patient qualifies for the trial.

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.

NCT04281498
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 2
Lead Sponsor

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

John Mascarenhas
Principal Investigator

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

John Mascarenhas, MDRuben Mesa, MDRonald Hoffman, MDMichal Bar-Natan, MD
Principal Investigator Affiliation Icahn School of Medicine at Mount SinaiMays Cancer Center at UT HealthIcahn School of Medicine at Mount SinaiIcahn School of Medicine at Mount Sinai
Agency Class

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

Other, Industry, NIH
Overall Status Recruiting
Countries Canada, United States
Conditions

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

Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis, IDH2 Mutation
Additional Details

At this time, there is no standard medical treatment for MPN-AP/BP and most patients with accelerated and blast phase MPN do not respond well to treatment This is a phase II open-label study to evaluate the safety and efficacy of combined ruxolitinib and enasidenib in patients with accelerated/blast-phase myeloproliferative neoplasm or chronic phase myelofibrosis with high risk features and IDH2 mutation. Ruxolitinib (Jakafi/Jakavi) is FDA approved for myelofibrosis and was shown to reduce splenomegaly and improve symptoms. Enasidenib is a potent inhibitor of the IDH2 mutant enzyme and is FDA approved for relapsed refractory AML where it showed effectivity. Pre-clinical studies indicate increased disease mitigating effects with the combination of enasidenib and ruxolitinib. This study will enroll up to 32 patients. Ruxolitinib and enasidenib will be given orally in 28-day cycles.

Arms & Interventions

Arms

Experimental: Patients with MPN

Ruxolitinib and Enasidenib combination therapy

Interventions

Drug: - Ruxolitinib

Patients who are on ruxolitinib will continue their current dose. Patients who are not on ruxolitinib will receive ruxolitinib dosing based on platelet count

Drug: - Enasidenib

50mg -100mg daily

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 - Arizona, Scottsdale, Arizona

Status

Not yet recruiting

Address

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259

Site Contact

Jeanne Palmer, MD

Palmer.Jeanne@mayo.edu

212-241-6772

Cedars-Sinai Medical Center, Los Angeles, California

Status

Not yet recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Ronald Paquette, MD

ronald.paquette@cshs.org

310-423-1160

Moffitt Cancer Center, Tampa, Florida

Status

Not yet recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

Andrew T. Kuykendall, MD

Andrew.Kuykendall@moffitt.org

813-745-6841

University of Kansas Cancer Center, Westwood, Kansas

Status

Not yet recruiting

Address

University of Kansas Cancer Center

Westwood, Kansas, 66205

Site Contact

Abdulraheem Yacoub, MD

ayacoub@kumc.edu

913-588-6029

Ann Arbor, Michigan

Status

Not yet recruiting

Address

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109-5936

Site Contact

Kristen Pettit, MD

krpettit@med.umich.edu

734-764-8195

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

Lonette Sandy

Lonette.Sandy@mssm.edu

212-241-4546

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

Status

Not yet recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Site Contact

Raajit Rampal, MD, PhD

rampalr@mskcc.org

212-639-2194

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Not yet recruiting

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

Site Contact

Rupali Roy Bhave, MD

rbhave@wakehealth.edu

336-716-1808

Taussig Cancer Center Institute, Cleveland, Ohio

Status

Recruiting

Address

Taussig Cancer Center Institute

Cleveland, Ohio, 44195

Site Contact

Aaron Gerds, MD, MS

gerdsa@ccf.org

216-445-9840

San Antonio, Texas

Status

Recruiting

Address

Mays Cancer Center at UT Health San Antonio

San Antonio, Texas, 78229

Site Contact

Ruben Mesa, MD

michal.bar-natan@mssm.edu

212-241-6772

International Sites

Princess Margaret Cancer Centre, Toronto, Canada

Status

Not yet recruiting

Address

Princess Margaret Cancer Centre

Toronto, , M5G 2M9

Site Contact

Vikas Gupta, MD, FRCP, FRCPath

vikas.gupta@uhn.ca

(416) 946-4521

Powered By
The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Recent Posts

  • Contemporary Approach CALR Positive MPNs
  • 9 Tips to Reduce MPN Fatigue
  • Common Clinical Trial Acronyms and Abbreviations
  • Understanding the Phases of Clinical Trials
  • 4th Angel providing one-on-one support services for MPN Patients
  • Serving the MPN cancer community with support services




Sign up for our Newsletter

Subscribers will receive updates from MPN-CC and PV Reporter!
* = required field

RSS News

  • Inflammatory Microenvironment & Specific T-Cells in MPNs
  • Covid-19 Vaccines FAQs for Patients and Caregivers
  • Precision Medicine and Gene Mutations in MPNs
  • New MPN Drug Treatments in Development
© 2021 MPN Cancer Connection. All Rights Reserved.
  • Terms
  • Privacy
  • Partners
  • About
  • Contact
MPN Cancer Connection
Malcare WordPress Security