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
Overview
- Phase
- Phase 2
- Intervention
- Oshadi D & Oshadi R;
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Oshadi Drug Administration
- Enrollment
- 15
- Primary Endpoint
- Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
- Status
- Suspended
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility 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
- •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.
Arms & Interventions
'Oshadi D & Oshadi R; salvage therapy'
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
Intervention: Oshadi D & Oshadi R;
'Oshadi D & Oshadi R; salvage therapy'
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
Intervention: salvage therapy cytosar and mitoxantrone
Outcomes
Primary Outcomes
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
Time Frame: 28 days
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
Secondary Outcomes
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(28 days)