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

• Status: Suspended
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oshadi Drug Administration
• Treatments: Antineoplastic Agents; Cytarabine; Mitoxantrone

Criteria

Inclusion Criteria:

• Patients is diagnosed as AML or ALL

• Relapse defined as the presence of disease after the achievement of complete remission(CR). Refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.

• Male or female ≥ 18 years of age

• Minimal performance status (ECOG 0, ≤2)

• Patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.

• Written informed consent

• Adequate hepatic function (LFTs up to X4 the normal limits), renal function calculated Creatinine clearance (CrCl) for Adverse Effects of >30)

• Ability to swallow the medications.

• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.

• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

• Active infectious disease uncontrolled by antibiotics.

• Partially treated induction patients (i.e. day 14 non responding patients).

• Inability to receive high dose salvage chemotherapy.

• Patient with known positive HIV serology at screening.

• Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.

• Evidence of ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for Adverse Effects (CTCAE ) Version 3.0 grade 2.

• Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.

• Mental disorders.

• Inability to give written informed consent.