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    • 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.
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Clinical Trial Finder

Clinical Trial Finder

Search Results

CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Study Purpose

This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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:

  • - Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) - Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment.
  • - MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2/high risk with excess blasts > 5%, or with 10-19% bone marrow blasts.
  • - No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents.
  • - Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
  • - Total bilirubin < 3 mg/dL (will allow less than 5 x upper limit of normal [ULN] if Gilbert's at investigator's discretion) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x ULN.
  • - Serum creatinine clearance > 30 mL/min and no end/stage renal disease.
  • - Hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient.

Exclusion Criteria:

  • - New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50 by echocardiogram or multigated acquisition (MUGA) scan.
  • - History of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias.
  • - Uncontrolled infection not adequately responding to appropriate antibiotics.
  • - Female patients who are pregnant or lactating.
  • - Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study.
  • - Female patients with reproductive potential who have a positive urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
- Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment) - Prior cumulative anthracycline exposure of > 550 mg/m^2 daunorubicin or equivalent, or > 400 mg/m^2 in patients who received radiation therapy to the mediastinum

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.

NCT03896269
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
Lead Sponsor

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

M.D. Anderson Cancer Center
Principal Investigator

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

Guillermo M Bravo
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

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

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

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

Blasts 10-19 Percent of Bone Marrow Nucleated Cells, Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, High Risk Chronic Myelomonocytic Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent High Risk Myelodysplastic Syndrome, Refractory Chronic Myelomonocytic Leukemia, Refractory High Risk Myelodysplastic Syndrome
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. To characterize the safety and tolerability of CPX-351 in patients with intermediate-2 or high-risk myelodysplastic syndrome (MDS).
(Dose Escalation Stage)
  • II. To determine the maximum tolerated dose (MTD) of intravenous CPX-351 in patients with intermediate-2 or high-risk MDS.
(Dose Escalation Stage)
  • III. To further characterize the safety and tolerability of CPX-351 in patients with intermediate-2 and high-risk MDS.
(Dose-Expansion Stage)
  • IV. To evaluate preliminary efficacy of CPX-351 in patients with intermediate-2 or high-risk MDS.
(Dose-Expansion Stage) SECONDARY OBJECTIVES:
  • I. To assess overall response (OR) rate.
  • II. To assess overall survival.
  • III. To assess duration of response.
  • IV. To assess relapse-free survival.
  • V. To assess safety profile.
OUTLINE: This is a dose-escalation study. INDUCTION THERAPY: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. After 2-5 weeks, patients who do not achieve a complete response (CR)/CR with incomplete bone marrow recovery (CRi)/CR with incomplete platelet recovery (CRp), have acceptable or no toxicity, and have stable disease and no disease progression may receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients who achieve at least a hematological improvement (HI) response, receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 5-8 weeks, patients who do not show clinically significant disease progression or unacceptable toxicity may receive liposome-encapsulated daunorubicin-cytarabine for up to 12 additional cycles. After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Arms & Interventions

Arms

Experimental: Treatment (liposome-encapsulated daunorubicin-cytarabine)

INDUCTION THERAPY: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. After 2-5 weeks, patients who do not achieve a CR/CRi/CRp, have acceptable or no toxicity, and have stable disease and no disease progression may receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients who achieve at least a HI response, receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 5-8 weeks, patients who do not show clinically significant disease progression or unacceptable toxicity may receive liposome-encapsulated daunorubicin-cytarabine for up to 12 additional cycles.

Interventions

Drug: - Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

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.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Guillermo M. Bravo

gmontalban1@mdanderson.org

713-794-3604

Nearest Location

Site Contact

Guillermo M. Bravo

gmontalban1@mdanderson.org

713-794-3604

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