Study to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety and drug/body interactions of EDO-S101 in patients with relapsed or resistant hematologic cancers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Sign an informed consent
  • Age ≥18 years
  • Diagnosis of relapsed or refractory lymphoid malignancy for which there are no available therapies
  • Discontinuation of previous cancer therapies at least 4 weeks prior to treatment in this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Neutrophils >1,000 µL
  • Platelets ≥75,000 µL
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 upper limit of normal (ULN)
  • Total bilirubin <2.0 mg/dL unless elevated due to known Gilbert's syndrome
  • Creatinine ≤1.5 ULN
  • Serum potassium within normal range
  • If female of child-bearing potential (i.e. not postmenopausal or surgically sterile) must be willing to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods
  • If male, must be sterile or willing to abstain from sexual intercourse or employ a barrier method of contraception during the study treatment and follow-up periods

Exclusion Criteria

  • Has primary central nervous system (CNS) lymphoma or CTCL
  • Diagnosis of acute leukemia or any patient that has been treated with fludarabine
  • Allogeneic stem cell transplant patients and any patient who has relapsed within 100 days of stem cell infusion following an autologous bone marrow transplant
  • QTc interval > 450 msec
  • On treatment with drugs known to prolong the QT/QTc interval
  • Any serious medical condition that interferes with adherence to study procedures
  • History of a second malignancy diagnosed within 3 years of study enrollment excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • Pregnant or breast feeding females
  • New York Heart Association (NYHA) stage III/IV congestive heart failure, arrhythmias not adequately controlled, active infections, or other significant co-morbidities [e.g. active central nervous system metastases and/or carcinomatous meningitis, active infection requiring systemic therapy, history of human immunodeficiency virus (HIV) infection, or active Hepatitis B or Hepatitis C
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed four (4) weeks prior to first dose of study drug or without complete recovery from all such treatments
  • Use of other investigational agents from 30 days prior to the screening visit through discontinuation of study drug
  • Steroid treatment within 7 days prior to study treatment
    • Patients that require intermittent use of bronchodilators, topical steroids or local steroid injections will not be excluded from the study
    • Patients who have been stabilized to 10 mg PO QD or less 7 days prior to study drug administration are allowed

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Han Tun, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Han Tun, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Han Tun, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions