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Clinical Trial 18390
Study Type: Treatment
Phase of Study: Phase I
- Jeffrey Lancet
A Phase 1 Dose Escalation, Multicenter, Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of FT-1101 In Patients With Relapsed or Refractory Hematologic Malignancies
The major purposes of this study are to determine the maximum dose of FT-1101 (study drug or the investigational drug) that can be tolerated, and once this dose is found, if it has any effect in patients with acute leukemia or myelodysplastic syndrome.
Primary: To determine the maximum tolerated dose (MTD), the dose limiting toxicities (DLT), and the FT-1101 dose recommended for future phase 2 studies (RP2D) for patients with relapsed refractory acute leukemia or high-risk myelodysplastic syndrome (MDS). Secondary: To determine the pharmacokinetics (PK) of FT-1101. To observe patients for any evidence of anti-leukemic or antimyelodysplastic activity of FT-1101, as determined by changes in complete blood count/differential bone marrow histology and physical exam.