Clinical trial · Interventional
Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Lymphoid Leukemia | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oshadi D & Oshadi R; | Drug | — | UNRESOLVED |
| salvage therapy cytosar and mitoxantrone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 'Oshadi D & Oshadi R; salvage therapy'
- description
- 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
- interventionNames
- Drug: Oshadi D & Oshadi R;
- Drug: salvage therapy cytosar and mitoxantrone
Primary outcomes (1)
- measure
- Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
- timeFrame
- 28 days
- description
- Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
Secondary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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