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  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

Dasatinib Holiday for Improved Tolerability

Study Purpose

Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability))

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:

- Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph+ chromosome [t(9;22)(q34;q11)].

- Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR4 will be also considered eligible.

- ECOG performance status ≤2.

- Age ≥ 18 years old (no upper age limit is given) - Serum levels of potassium, magnesium and total calcium within the normal limits (≥LLN [lower limit of normal] and ≤ULN [upper limit of normal]).

Correction of electrolytes' levels with supplements to meet enrolment criteria is allowed.

- AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia.

- Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia.

- Total bilirubin ≤1.5 x ULN, except known Gilbert disease.

- Serum creatinine ≤2 x ULN.

- Written informed consent prior to any study procedures being performed.

For 1st-line patients: • Pre-treatment with hydroxyurea up to 6 months and imatinib or dasatinib for duration of up to 4 weeks is permitted. For ≥ 2nd-line patients: • Patients with treatment failure according to the 2013 ELN Recommendations criteria3 or treatment intolerance as assessed by the investigator after prior treatment with TKIs other than dasatinib (imatinib, nilotinib, bosutinib, ponatinib).

Exclusion Criteria:

- Previous allogeneic stem cell transplantation (AlloSCT) - Known impaired cardiac function, including any of the following: - Congenital long QT syndrome.

- History of or presence of clinically significant ventricular or atrial tachyarrhythmia.

- QTc >450 msec on screening ECG.

- Myocardial infarction within 6 months prior to starting therapy.

- Other clinical significant heart disease (e.g. unstable angina pectoris, congestive heart failure) - Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled.

- Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.

- Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) - Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4.

- Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.

- Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control.

Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of dasatinib. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) - Active autoimmune disorder, including autoimmune hepatitis.

- Known serious hypersensitivity reactions to dasatinib.

- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.

- Patients unwilling or unable to comply with the 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.	NCT02890784
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 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Jena
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andreas Hochhaus, Prof.
Principal Investigator Affiliation	Jena University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myeloid Leukemia, Chronic

Additional Details

Dasatinib is indicated in Europe for:

- Treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.

- Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.

- Ph+ acute lymphoblastic leukemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy Compared to imatinib, dasatinib in CML achieves faster and better responses.

Dasatinib is known for its selected toxicities (fluid retention, edema, pleural effusion, and hematological toxicity) requiring dose reductions or treatment interruptions; these toxicities are more frequent in the first two years of treatment. A randomized dose optimization trial for QD dosing vs.#46; BID dosing has demonstrated non-inferiority with regards to efficacy with an improved toxicity profile. In a pilot study, analyzing patients with dasatinib toxicity, a fixed dasatinib weekend holiday allowed safe toxicity management without impairing efficacy. Furthermore the alternated schedule was also able to improve response parameters in patients that had never achieved an acceptable response prior to the onset of dasatinib holiday dosing schedule. The biological rationale for a holiday dosing schedule is that dasatinib has shown an improved cell death of CML cells even after short exposure times; this improved cell death exceeds the killing rate observed with imatinib in vitro. In summary, the reported preclinical and clinical evidence indicates that efficacy seems to require adequate dasatinib Cmax, while low Cmin (five half-lives between doses) does not impair efficacy nor induces drug resistance. It is speculated that a weekend holiday, allowing a better tolerability, would improve patients' drug adherence. The Investigators hypothesize that a dasatinib holiday schedule (5x100mg+2x0mg weekly) compared to a regular dose (7x100mg weekly) will reduce the rate of clinically significant toxicity (e.g., fluid retention, hematological toxicity, musculoskeletal pain) by 20% observed within the first two years of treatment. The Investigators also hypothesize that the dasatinib holiday schedule is non-inferior to dasatinib regular dose in achieving the European LeukemiaNet (ELN) recommended levels of response within the first 24 months.

Arms & Interventions

Arms

Active Comparator: A. Standard arm

100mg dasatinib (SPRYCEL®) daily dose (QD) (7x100) (Standard therapy)

Experimental: B. Study arm

100mg dasatinib (SPRYCEL®) (QD) weekdays (1-5) only (5x100+2x0) (overall dose reduction per week)

Interventions

Drug: - dasatinib (SPRYCEL®)

Treatment optimization for patients with chronic myeloid leukemia (CML)

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.

International Sites

Uniklinik der RWTH Aachen, Aachen, Germany

Status

Recruiting

Address

Uniklinik der RWTH Aachen

Aachen, , 52074

Site Contact

Martina Crysandt, Dr. med.