Acute Myeloid LeukemiaPhase 2NCT02462265
Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients
A Phase 2 study testing Oshadi D & Oshadi R; and salvage therapy cytosar and mitoxantrone in people with Acute Myeloid Leukemia and Lymphoid Leukemia, run by Oshadi Drug Administration.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Lymphoid Leukemia
- What is being tested?
- Oshadi D & Oshadi R; and salvage therapy cytosar and mitoxantrone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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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)
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
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
- Acute Myeloid Leukemia, Lymphoid Leukemia
- Being tested
- Oshadi D & Oshadi R;, salvage therapy cytosar and mitoxantrone
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi D & Oshadi R;Drug
Also called Anti cancer agents
Oshadi D (180mg/TID) \& Oshadi R (180mg TID) will be administrated;
salvage therapy cytosar and mitoxantroneDrug
Also called anti cancer agents
Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)
| Study group | Role | What they receive |
|---|---|---|
| 'Oshadi D & Oshadi R; salvage therapy' | Experimental | 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 Receives: Drug: Oshadi D & Oshadi R;; Drug: salvage therapy cytosar and mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJan 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Gatt, MD, Principal investigator, Hadassah Medical Center, Jrusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462265
- Sponsor's protocol ID
- OS-AM-P2-01 Version 0.1
- Status last verified
- Apr 2018
- First submitted
- 26 May 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02462265
- Acronym / sponsor ID
- OS-AM-P2-01 Version 0.1
- Conditions
- Acute Myeloid Leukemia, Lymphoid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'Oshadi D & Oshadi R; salvage therapy' | Experimental | Drug: Oshadi D & Oshadi R;, Drug: salvage therapy cytosar and mitoxantroneOshadi 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oshadi D & Oshadi R;Also: Anti cancer agentsOshadi D (180mg/TID) \& Oshadi R (180mg TID) will be administrated; | Drug | 'Oshadi D & Oshadi R; salvage therapy' |
| salvage therapy cytosar and mitoxantroneAlso: anti cancer agentsSalvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) | Drug | 'Oshadi D & Oshadi R; salvage therapy' |
Primary outcome
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.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Gatt, MD principal investigator
Hadassah Medical Center, Jrusalem, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oshadi D & Oshadi R; and salvage therapy cytosar and mitoxantrone in people with Acute Myeloid Leukemia and Lymphoid Leukemia, run by Oshadi Drug Administration.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.