Hematologic DiseasesPhase 1NCT04243434
PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients
A Phase 1 study testing Vincristine Sulfate Liposome, CHOP and R-CHOP in people with Hematologic Diseases, run by Acrotech Biopharma Inc..
Trial summary
This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Vincristine Sulfate Liposome, CHOP and R-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2020to 15 Oct 2020
- Phase
- Phase 1
- 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
- Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.
- Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:
- Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.
Who cannot join
- Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.
- Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
- Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
- Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.
- Patient has severe, active and uncontrolled hepatic disease or dysfunction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies
This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.
Read the detailed description
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) in which the Marqibo formulation and the 1-vial VSLI-RTU formulation of vincristine are administered in a 2-way crossover design over 2 treatment cycles (21 days each):
- Cohort A: Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
- Cohort B: VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
Both formulations of vincristine sulfate LIPOSOME injection will be administered via a 60 (±10) minute IV infusion.
Blood samples for PK evaluation will be drawn at the following time points: immediately before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion (EOI), and 3, 8, 15, 24, 48, 72, and 96 hours post-EOI.
In addition to Marqibo or VSLI-RTU, all patients will receive standard doses (per institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and rituximab if patient is on the R-CHOP regimen), on Day 1 and prednisone (or prednisolone if consistent with institutional or regional guidelines) on Days 2 to 5.
- Conditions
- Hematologic Diseases
- Being tested
- Vincristine Sulfate Liposome, CHOP, R-CHOP
- Keywords
- Hematology, Hematological Malignancy, CHOP, R-CHOP
- Medical subject headings
- Hematologic Diseases, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vincristine Sulfate LiposomeDrug
Also called Marqibo
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle.
CHOPCombination product
Also called cyclophosphamide. doxorubicin, vincristine , and prednisone, Adriamycin, (Oncovin)
CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle)
R-CHOPCombination product
Also called cyclophosphamide. doxorubicin, vincristine , prednisone + Rituximab
R-CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2. Receives: Drug: Vincristine Sulfate Liposome; Combination Product: CHOP; Combination Product: R-CHOP |
| Cohort B | Experimental | VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2. Receives: Drug: Vincristine Sulfate Liposome; Combination Product: CHOP; Combination Product: R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK analysis Area under the concentration time curve (AUC)
To evaluate the serum pharmacokinetics (PK) of the 1-vial VSLI-RTU formulation versus the current Marqibo 3-vial formulation for intravenous (IV) injection.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start15 Aug 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited
- Responsible party
- Sponsor
- Investigators
- Wasim Khan, MD, Study director, Acrotech Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243434
- Sponsor's protocol ID
- SPI-MAR-101
- Status last verified
- Apr 2020
- First submitted
- 17 Oct 2019
- Last updated
- 16 Apr 2020
- 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 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04243434
- Acronym / sponsor ID
- SPI-MAR-101
- Conditions
- Hematologic Diseases
- Keywords
- Hematology, Hematological Malignancy, CHOP, R-CHOP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 28 Jan 2020 (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.
This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.
Detailed description
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) in which the Marqibo formulation and the 1-vial VSLI-RTU formulation of vincristine are administered in a 2-way crossover design over 2 treatment cycles (21 days each):
- Cohort A: Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
- Cohort B: VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
Both formulations of vincristine sulfate LIPOSOME injection will be administered via a 60 (±10) minute IV infusion.
Blood samples for PK evaluation will be drawn at the following time points: immediately before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion (EOI), and 3, 8, 15, 24, 48, 72, and 96 hours post-EOI.
In addition to Marqibo or VSLI-RTU, all patients will receive standard doses (per institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and rituximab if patient is on the R-CHOP regimen), on Day 1 and prednisone (or prednisolone if consistent with institutional or regional guidelines) on Days 2 to 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Vincristine Sulfate Liposome, Combination Product: CHOP, Combination Product: R-CHOPMarqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2. |
| Cohort B | Experimental | Drug: Vincristine Sulfate Liposome, Combination Product: CHOP, Combination Product: R-CHOPVSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.
- Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:
- Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.
Key exclusion criteria (5 listed)
- Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.
- Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
- Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
- Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.
- Patient has severe, active and uncontrolled hepatic disease or dysfunction.
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 |
|---|---|---|
| Vincristine Sulfate LiposomeAlso: MarqiboEligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle. | Drug | Cohort A, Cohort B |
| CHOPAlso: cyclophosphamide. doxorubicin, vincristine , and prednisone, Adriamycin, (Oncovin)CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle) | Combination product | Cohort A, Cohort B |
| R-CHOPAlso: cyclophosphamide. doxorubicin, vincristine , prednisone + RituximabR-CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle) | Combination product | Cohort A, Cohort B |
Primary outcome
PK analysis Area under the concentration time curve (AUC)
Time frame: 6 weeks
To evaluate the serum pharmacokinetics (PK) of the 1-vial VSLI-RTU formulation versus the current Marqibo 3-vial formulation for intravenous (IV) injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- 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.
Wasim Khan, MD study director
Acrotech Biopharma Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vincristine Sulfate Liposome, CHOP and R-CHOP in people with Hematologic Diseases, run by Acrotech Biopharma 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Melissa Brugard, CTM, MSW (218.284.9863, m.burgard@axisclinicals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK analysis Area under the concentration time curve (AUC) (time frame: 6 weeks). 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 16 Apr 2020.