Acute Myeloid LeukemiaPhase 2NCT03187691
Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
A Phase 2 study testing Oral Encochleated Amphotericin B (CAMB) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Matinas BioPharma Nanotechnologies, Inc..
Trial summary
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Oral Encochleated Amphotericin B (CAMB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2020
- 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
- Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3
- Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
- Sign informed consent
- ≥ 18 years of age
Who cannot join
- Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
- Fungal induced fever (≥ 38°C)
- Proven, possible or probably invasive fungal infection in previous 12 months
- Serum galactomannan index (GMI)≥ 0.5 at screening
- Pulmonary infiltrates at screening
- Current treatment with amphotericin B
Show all 15Show fewer
- Sever comorbidity other than underlying haematological disease
- Prolongation of corrected QT interval
- History of convulsion
- Pregnant or breastfeeding
- Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
- Presence of hepatic disease
- Total bilirubin > 3 x upper limit of normal
- Age-adjusted creatinine clearance < 30 mL/minute
- Participating in any other clinical study
About this study
Official title: An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
Read the detailed description
This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.
- Being tested
- Oral Encochleated Amphotericin B (CAMB)
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Encochleated Amphotericin B (CAMB)Drug
Also called MAT2203
Lipid-crystal nano-particle formulation amphotericin B
| Study group | Role | What they receive |
|---|---|---|
| CAMB 200 mg | Experimental | 200 mg CAMB (MAT2203) Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
| CAMB 400 mg | Experimental | 400 mg CAMB (MAT2203) Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
| CAMB 800mg | Experimental | 800 mg CAMB (MAT2203) Oral Amphotericin B Receives: Drug: Oral Encochleated Amphotericin B (CAMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Safety assessments include laboratory tests, vital signs, physical exam and ECG
Measured: 35 days
Secondary outcomes (4)
Population pharmacokinetic (PK) analysis
PK parameter for Time to maximum concentration (Tmax)
Measured: 35 days
Population pharmacokinetic (PK) analysis
PK parameter for Peak plasma concentration (Cmax)
Measured: 35 days
Population pharmacokinetic (PK) analysis
PK parameter for Area under the plasma concentration time curve (AUC)
Measured: 35 days
Efficacy analysis for time to clinical symptoms of fungal infection
Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startAug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Protocol redundancy
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized, open uncontrolled
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cologne, The Clinical Trials Centre Cologne
- Responsible party
- Sponsor
- Investigators
- Oliver Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187691
- Sponsor's protocol ID
- MB-70006
- Status last verified
- Mar 2019
- First submitted
- 31 May 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
- ClinicalTrials.gov ID
- NCT03187691
- Acronym / sponsor ID
- MB-70006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol redundancy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Cologne, The Clinical Trials Centre Cologne
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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.
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
Detailed description
This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non-randomized, open uncontrolled
| Arm | Type | Receives |
|---|---|---|
| CAMB 200 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)200 mg CAMB (MAT2203) Oral Amphotericin B |
| CAMB 400 mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)400 mg CAMB (MAT2203) Oral Amphotericin B |
| CAMB 800mg | Experimental | Drug: Oral Encochleated Amphotericin B (CAMB)800 mg CAMB (MAT2203) Oral Amphotericin B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3
- Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
- Sign informed consent
- ≥ 18 years of age
Key exclusion criteria (15 listed)
- Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
- Fungal induced fever (≥ 38°C)
- Proven, possible or probably invasive fungal infection in previous 12 months
- Serum galactomannan index (GMI)≥ 0.5 at screening
- Pulmonary infiltrates at screening
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 |
|---|---|---|
| Oral Encochleated Amphotericin B (CAMB)Also: MAT2203Lipid-crystal nano-particle formulation amphotericin B | Drug | CAMB 200 mg, CAMB 400 mg, CAMB 800mg |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 35 days
Safety assessments include laboratory tests, vital signs, physical exam and ECG
4 secondary outcomes
Population pharmacokinetic (PK) analysis
Time frame: 35 days
Population pharmacokinetic (PK) analysis
Time frame: 35 days
Population pharmacokinetic (PK) analysis
Time frame: 35 days
Efficacy analysis for time to clinical symptoms of fungal infection
Time frame: 35 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Oliver Cornely, MD principal investigator
University of Cologne
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Encochleated Amphotericin B (CAMB) in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Matinas BioPharma Nanotechnologies, Inc..
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 8 Mar 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment emergent adverse events (time frame: 35 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 8 Mar 2019.