Acute Myeloid Leukemia, Lymphoid Leukemia
Conditions
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.
Interventions
DRUGOshadi D & Oshadi R;
Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated;
DRUGsalvage therapy cytosar and mitoxantrone
Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)
Sponsors
Oshadi Drug Administration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. | 28 days | Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 28 days | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Outcome results
None listed