Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: '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 |
Drug: Oshadi D & Oshadi R;
Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated;
Other Names:
Drug: salvage therapy cytosar and mitoxantrone
Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients is diagnosed as AML or ALL
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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.
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Male or female ≥ 18 years of age
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Minimal performance status (ECOG 0, ≤2)
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Patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
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Written informed consent
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Adequate hepatic function (LFTs up to X4 the normal limits), renal function calculated Creatinine clearance (CrCl) for Adverse Effects of >30)
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Ability to swallow the medications.
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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.
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Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
Exclusion Criteria:
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Active infectious disease uncontrolled by antibiotics.
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Partially treated induction patients (i.e. day 14 non responding patients).
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Inability to receive high dose salvage chemotherapy.
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Patient with known positive HIV serology at screening.
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Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
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Evidence of ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for Adverse Effects (CTCAE ) Version 3.0 grade 2.
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Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
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Mental disorders.
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Inability to give written informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oshadi Drug Administration
Investigators
- Principal Investigator: Moshe Gatt, MD, Hadassah Medical Center, Jrusalem, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OS-AM-P2-01 Version 0.1