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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

ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor

Study Purpose

This phase II trial studies how well ABL001 works in treating patients with chronic myeloid leukemia who are on therapy with tyrosine kinase inhibitor. ABL001 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ABL001 and tyrosine kinase inhibitor together may work better than tyrosine kinase inhibitor alone in treating patients with chronic myeloid leukemia.

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:

  • - Patients with a diagnosis of Philadelphia chromosome (Ph)- or BCR-ABL1-positive CML (as determined by cytogenetics, fluorescence in situ hybridization [FISH], or polymerase chain reaction [PCR]) - Patients should be receiving therapy with nilotinib or dasatinib, whether as initial therapy or after prior TKI, at a dose equal or lower than the standard dose.
  • - Patients must have received TKI therapy for at least 24 months and not have required dose reductions, escalations, discontinuation or re-initiation after discontinuation of TKI in the last 6 months.
  • - Patients must be in CCyR (by conventional karyotype or FISH, or BCR-ABL/ABL =< 1% IS if no cytogenetic analysis available within 3 months) - Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: a.
Patient has never achieved a MMR after 18 months of therapy with their current TKI, or b. Patient has not achieved MR4.5 after 36 months of therapy with their current TKI, or c. Patient has lost MMR or MR4.5 confirmed in at least two consecutive analyses separated by at least 1 month, or d. BCR-ABL1 transcript levels have reached a plateau defined as a ratio that is stable in a molecular response category (i.e., MMR, MR4 or MR4.5) in the last at least 12 months, with at least 3 values obtained during this period.
  • - Patients must not have had a known continuous interruption of TKI therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment, unless the interruption was for an accident, unrelated hospitalization or surgical procedure, or for a treatment-free remission attempt that was unsuccessful and required re-initiation of therapy.
  • - Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
  • - Creatinine =<1.5 x institutional upper limit of normal.
  • - Amylase and lipase values =< 3.0 x institutional upper limit of normal.
  • - Alkaline phosphatase =< 2.5 x institutional upper limit of normal unless considered to be not of hepatic origin.
  • - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal.
  • - Total bilirubin =< 1.5 x institutional upper limit of normal (=< 3 x upper limit of normal in patients with known Gilbert's syndrome) - The effects of ABL001 on the developing human fetus are unknown.
For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must agree to use highly effective methods of contraception during dosing and for 30 days after study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Allowable methods of birth control: Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before the start of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject. Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

Exclusion Criteria:

  • - Patients with New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 40% by echocardiogram or multigated acquisition (MUGA) scan.
  • - Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias.
Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block)
  • - Corrected QT interval (QTc) of > 480 milliseconds (ms) on baseline electrocardiogram (ECG) (using corrected QT interval per institutional standard) - Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: a.
Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. b. Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointes that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
  • - Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
  • - Patients with known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally.
  • - Nursing women, women of childbearing potential (WOCBP) with positive blood or urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
  • - History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
  • - Absolute neutrophil count (ANC) < 500/mm^3.
  • - Platelet count < 50,000 mm^3.
  • - History of other active malignancy within 2 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
  • - Treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with study treatment: Moderate or strong inducers of CYP3A.
Moderate or strong inhibitors of CYP3A and/or P-glycoprotein (P-gp). Substrates of CYP3A4/5, CYP2C8, or CYP2C9 with narrow therapeutic index.
  • - Previous treatment with or known/ suspected hypersensitivity to ABL001 or any of its excipients.
- Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study

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.

NCT04216563
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.

M.D. Anderson Cancer Center
Principal Investigator

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

Ghayas C Issa
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.

Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVE:

  • I. To determine the clinical activity of the combination of asciminib (ABL001) and a tyrosine kinase inhibitor (TKI) in patients with chronic myeloid leukemia (CML) in complete cytogenetic response (CCyR) but detectable BCR-ABL1 transcript.
SECONDARY OBJECTIVES:
  • I. To determine the effect of the combination of ABL001 and TKI on the rate of mismatch repair (MR)4, MR4.5, and sustained MR4.5.
  • II. To investigate treatment-free remission after at least 2 years of sustained deep molecular remission.
  • III. To determine the safety of the combination of asciminib and tyrosine kinase inhibitors.
  • IV. To determine the event-free survival (EFS), survival free from transformation to accelerated and blast phase (TFS), and overall survival (OS).
EXPLORATORY OBJECTIVES:
  • I. To determine the rate of minimal residual disease (MRD) clearance using droplet digital polymerase chain reaction (ddPCR) detecting the BCR-ABL1 fusion transcript.
  • II. To determine the effect of therapy on quiescent leukemic Philadelphia chromosome positive (Ph+) stem cells (CFSEmax/CD34+).
  • III. To determine the effect of this combination on mutations in ABL1 and mutations in clonal hematopoiesis of indeterminate potential (CHIP)-associated genes using molecular barcode sequencing.
  • IV. To determine the effect of therapy on bone marrow progenitors in clonogenic assays.
  • V. To describe immune effects of the combination of TKI and ABL001.
  • VI. To describe patient reported outcomes (PRO) using the MD Anderson Symptom Inventory (MDASI)-CML instrument.
OUTLINE: Patients receive asciminib orally (PO) twice daily (BID) for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator. After completion of study treatment, patients are followed up every 4-8 weeks for 6 months and then every 3-6 months thereafter.

Arms & Interventions

Arms

Experimental: Treatment (asciminib)

Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.

Interventions

Drug: - Asciminib

Given PO

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

Ghayas C. Issa

gcissa@mdanderson.org

713-745-6798

Nearest Location

Site Contact

Ghayas C. Issa

gcissa@mdanderson.org

713-745-6798

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