NCT02462265

Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients

A Phase II, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Salvage Chemotherapy for Relapsed or Refractory Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) Patients

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Oshadi Drug Administration · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile. Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R. Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.

Conditions

• Acute Myeloid Leukemia
• Lymphoid Leukemia

Interventions

Type	Name	Description
DRUG	Oshadi D & Oshadi R;	Oshadi D (180mg/TID) \& Oshadi R (180mg TID) will be administrated;
DRUG	salvage therapy cytosar and mitoxantrone	Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-06-04
• Last updated: 2018-04-18