Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
estimated completion

Description

Summary

Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated AML with adverse or intermediate genetic risk.

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Details

A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dociparstat sodium in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly-diagnosed AML patients.

Keywords

Acute Myeloid Leukemia AML Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Heparin Dociparastat sodium Dociparstat sodium (DSTAT)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Newly diagnosed, previously untreated AML (according to World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow.
  2. Age 18 to <60 years with adverse genetic risk, OR Age >=60 with intermediate or adverse genetic risk (according to ELN criteria).
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 if ≤79 years of age; ECOG status of 0 or 1 if ≥80 years of age.

You CAN'T join if...

  1. Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia.
  2. AML with a history of antecedent myelodysplasia that has been previously-treated (e.g., with a hypomethylating agent).
  3. Therapy-related AML after prior radiotherapy or chemotherapy for another cancer or disorder.
  4. Clinical evidence of active central nervous system leukemia.
  5. AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study.
  6. Receiving any form of anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin, coumadin, factor Xa inhibitors). Heparin flush of indwelling catheters is permitted.
  7. Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline.
  8. Any major surgery or radiation therapy within 28 days prior to baseline.
  9. Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
  10. . Active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant gastrointestinal bleeding within the 3 weeks prior to randomization.
  11. . Presence of significant active or uncontrolled infection, including HIV or hepatitis B or C.
  12. . Active (uncontrolled, metastatic) second malignancy.
  13. . History of severe congestive heart failure or other cardiac disease that contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%).
  14. . QTc >450 msec for a male, >470 msec for a female, or >480 msec if underlying bundle branch block.
  15. . Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
  16. . Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Chimerix
ID
NCT04571645
Phase
Phase 3
Study Type
Interventional
Last Updated