Lymphoma, Non-HodgkinPhase 1NCT03057418
Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
A Phase 1 study testing Aurixim in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by Biointegrator LLC at 3 sites in Russia.
Trial summary
This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
- What is being tested?
- Aurixim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesRussia
- Study dates
- Jun 2013to Dec 2016
- 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
- To participate in the clinical study, patients must comply to the following criteria:
- Signed patient's information sheet and informed consent form
- Males and females aged ≥ 18 years
- The expected survival time not less than 6 months, with no need of an urgent intervention to eliminate life-threatening complications
- Histologically and clinically confirmed at the screening diagnosis of В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or follicular lymphoma, according to WHO's (World Health Organization) classification as of year 2008, namely:
- Follicular lymphoma, cytological stage 1, 2 and 3a
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- Lymphoma from small lymphocytes (Small Lymphocytic Lymphoma) with number of peripheral blood lymphocytes < 5,000/mсl
- Lymphoplasmacytic lymphoma, including Waldenstrom's macroglobulinemia with paraprotein meaning (IgM ) > 2,0 g/l
- Extranodal marginal zone B-cell lymphoma of MALT-type
- Nodal marginal zone B-cell lymphoma (± monocytoid В- lymphocytes)
- Lymphoma of lien marginal zone cells.
- Patients did not receive any therapy for the main disease, or disease recurrence, or refractivity after the previous therapy
- II, III or IV disease stage according to Ann Arbor's classification and indications for immunotherapy, in the Investigator's opinion
- The patient must have at least one 2-view measurable lesion (size by the long axis > 1,5 cm and size by the short axis > 1,0 cm, measured by means of CT scanner), that did not undergo radiotherapy in the past or appeared again in the course of the previous treatment.
- Patients must have an ECOG status of 0 - 2
- Requirements for laboratory parameters determined below:
- Hematology: Absolute neutrophil count:
- Platelets:
- Hemoglobin: ≥ 1500/mm3 (1.5 x 109 cells/L)
- 100 000/mm3 (100 x 109 cells/L)
- 8.0 g/dl
- Liver function: Total bilirubin:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤ 1.5 x ULN
- ≤ 2.5 x ULN Renal function: GFR (according to Cocroft-Golt formula): > 30 ml/min.
- The patients must be practicing effective methods of birth control during the whole period of the study and 12 months after the last administration of the investigational product.
Who cannot join
- The patient will be considered ineligible for the study in case he/she has any criteria listed here below:
- Chronic lymphocytic leukemia
- CNS invasion now or in the history (lymphoma of CNS or lymphomatous meningitis)
- Treatment by chemotherapeutic agents or radiotherapy within 4 weeks before screening, treatment by nitrosourea and mitomycin C within 6 weeks before screening or presence of ongoing toxicities of ≥ II grade according to CTCAE, related to the prior therapy (excluding alopecia)
- Prior treatment by MAb (monoclonal antibodies) within 3 months before screening
- Concomitant immunosupressive therapy and systemic treatment by corticosteroids on the moment of screening.
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- Clinically significant cardiovascular diseases:
- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- Congestive heart failure Class III or IV according to the New York Heart Association (NYHA) criteria
- Clinically significant ventricular arrhythmia (ventricular tachycardia, ventricular fibrillation)
- QTc interval > 460 ms (ECG) (calculated according to Fredericia formula), or a diagnosis of long QTc syndrome
- Ejection fraction of left ventricle ≤ 50% (EchoCG)
- Hypotension (systolic arterial blood pressure < 86 mm of mercury) or bradycardia with a heart rate of < 50 beats per min., except when caused by medications (e.g. beta-blockers)
- Uncontrolled arterial hypertension (systolic arterial blood pressure > 170 mm of mercury or diastolic arterial blood pressure > 105 mm of mercury)
- Peripheral neuropathy ≥ III severity level
- Primary or secondary immunodeficiency now or in the history
- Presence of antibodies to human immunodeficiency virus (HIV), or hepatitis С virus (HCV), active hepatitis B
- Tuberculosis during last 5 years or positive result of the Quantiferon test
- Active infection within 4 weeks before screening
- Surgical interference (excluding biopsy of lymphatic nodes) within 4 weeks before screening
- History of other malignancies with the exception of cervical carcinoma in situ or skin basal-cell carcinoma, that had undergone surgical removal and treatment within ≥ 5 years before screening
- Uncontrolled concomitant diseases and conditions, including mental or social, which, in the Investigator's opinion, may prevent the patient from participation in the study.
- Hypersensitivity to any of medicinal agents used in this study, to their compounds or to murine proteins, as well as significant, in the Investigator's opinion, allergic reactions in the history
- Participation in other clinical studies or administration of other investigational products within 30 days before screening, or ongoing adverse reactions to any investigational product
- Drug or alcohol abuse on the moment of screening or in the past, which, in the Investigator's opinion, makes the patient unsuitable for participation in the study.
- Pregnant or lactating women, or women who plan to get pregnant during the clinical study; women of childbearing potential (not sterile and in postmenopause less than 2 years) who do not practice effective methods of birth control. Effective methods of birth control include usage of:
- oral, injectable or transdermal contraceptives
- a condom or diaphragm (barrier method) with spermicide, or
- intrauterine device
- Inability to read or write, unwillingness to understand and comply with the procedures of the study protocol, as well as any other concomitant medical or serious mental conditions, that make the patient unsuitable for participation in the clinical study, limit the validity of informed consent receipt or may affect the patient's ability to participate in the study -
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State Budgetary Public Healthcare Institution of the Nizhni Novgorod Region "Hospital of Ambulance of Dzerzhinsk city"
Dzerzhinsk, 606019
Federal State Budgetary Institution "National Medical-Surgical Center n.a. N.I.Pirogov" of the Ministry of Health of the Russian Federation
Moscow, 105203
Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N.Blokhin" of the Russian Academy of Medical Sciences
Moscow, 115478
About this study
Official title: Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim Multiple Doses in Patients With Recurrent/Refractory В-cell, CD20-positive Non-Hodgkin Lymphoma of Low Tumor Grade or With Follicular Lymphoma
This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade.
The study will be carried out in 4-6 Russian and Belarussian sites. The study will be consisted of screening period, induction (obligatory) phase and supporting (non-obligatory) phase of the investigational therapy and post-treatment follow-up period.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
- Being tested
- Aurixim
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriximDrug
Also called CON-4619
Administration will be performed once a week during 4-week induction period, and then once per 12 weeks during supporting period, if necessary. Total maximum duration of the investigational therapy - 1 year, during which patients will receive up to 8 infusions of Aurixim.
| Study group | Role | What they receive |
|---|---|---|
| Aurixim | Experimental | Dosage: 125 mg/m2, 250 mg/m2, 375 mg/m2 and 500 mg/m2. Formulation: concentrate for preparation of infusions 500 mg/50 ml and 100 mg/10 ml.
Mode of administration: intravenous. Receives: Drug: Aurixim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
The number of patients with treatment-related AEs assessed by CTCAE, abnormal laboratory values and instrumental tests (ECG) that are related to treatment.
Measured: Up to 24 weeks after the last dose
Maximum tolerated dose (MTD) of Aurixim
MTD is defined as maximum dose at which DLT occurs in more than 1 patient of 6
Measured: at Day 36 after the first dose
Secondary outcomes (4)
Area under the plasma concentration versus time curve (AUC)
PK analysis of multiple doses of Aurixim after single and multiple dosage
Measured: Up to week 71
CD19+
Pharmacodynamics (PD) of multiple doses of Aurixim after single and multiple
Measured: Up to week 71
Peak Plasma Concentration (Cmax)
PK analysis of multiple doses of Aurixim after single and multiple dosage
Measured: Up to week 71
Elimination half-life (T1/2)
PK analysis of multiple doses of Aurixim after single and multiple dosage
Measured: Up to week 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointegrator LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057418
- Sponsor's protocol ID
- ONC-CON4619-01
- Status last verified
- May 2017
- First submitted
- 8 Feb 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim Multiple Doses in Patients With Recurrent/Refractory В-cell, CD20-positive Non-Hodgkin Lymphoma of Low Tumor Grade or With Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT03057418
- Acronym / sponsor ID
- ONC-CON4619-01
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Biointegrator LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Feb 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.
This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade.
The study will be carried out in 4-6 Russian and Belarussian sites. The study will be consisted of screening period, induction (obligatory) phase and supporting (non-obligatory) phase of the investigational therapy and post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aurixim | Experimental | Drug: AuriximDosage: 125 mg/m2, 250 mg/m2, 375 mg/m2 and 500 mg/m2. Formulation: concentrate for preparation of infusions 500 mg/50 ml and 100 mg/10 ml. Mode of administration: intravenous. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Signed patient's information sheet and informed consent form
- Males and females aged ≥ 18 years
- The expected survival time not less than 6 months, with no need of an urgent intervention to eliminate life-threatening complications
- Histologically and clinically confirmed at the screening diagnosis of В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or follicular lymphoma, according to WHO's (World Health Organization) classification as of year 2008, namely:
- Patients did not receive any therapy for the main disease, or disease recurrence, or refractivity after the previous therapy
Key exclusion criteria (31 listed)
- The patient will be considered ineligible for the study in case he/she has any criteria listed here below:
- Chronic lymphocytic leukemia
- CNS invasion now or in the history (lymphoma of CNS or lymphomatous meningitis)
- Treatment by chemotherapeutic agents or radiotherapy within 4 weeks before screening, treatment by nitrosourea and mitomycin C within 6 weeks before screening or presence of ongoing toxicities of ≥ II grade according to CTCAE, related to the prior therapy (excluding alopecia)
- Prior treatment by MAb (monoclonal antibodies) within 3 months before 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 |
|---|---|---|
| AuriximAlso: CON-4619Administration will be performed once a week during 4-week induction period, and then once per 12 weeks during supporting period, if necessary. Total maximum duration of the investigational therapy - 1 year, during which patients will receive up to 8 infusions of Aurixim. | Drug | Aurixim |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Up to 24 weeks after the last dose
The number of patients with treatment-related AEs assessed by CTCAE, abnormal laboratory values and instrumental tests (ECG) that are related to treatment.
Maximum tolerated dose (MTD) of Aurixim
Time frame: at Day 36 after the first dose
MTD is defined as maximum dose at which DLT occurs in more than 1 patient of 6
4 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to week 71
CD19+
Time frame: Up to week 71
Peak Plasma Concentration (Cmax)
Time frame: Up to week 71
Elimination half-life (T1/2)
Time frame: Up to week 71
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aurixim in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by Biointegrator LLC at 3 sites in Russia.
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 25 inclusion and 31 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: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Safety and Tolerability) (time frame: Up to 24 weeks after the last dose). The study lists 2 primary outcomes in all. 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 23 May 2017.