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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Lymphoid Leukemia

Intervention / Treatment
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* Drug: Oshadi D & Oshadi R;
* Drug: salvage therapy cytosar and mitoxantrone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Oshadi D & Oshadi R; salvage therapy'<br>Oshadi D (180mg/tid) & Oshadi R (180mg/tid) will be administrated orally; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) will be administrated | Drug: Oshadi D & Oshadi R;<br>* Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated;<br>* Other names: Anti cancer agents;Drug: salvage therapy cytosar and mitoxantrone<br>* Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)<br>* Other names: anti cancer agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. | Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 28 days |