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| Name | Class |
|---|---|
| Cleveland BioLabs, Inc. | INDUSTRY |
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Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety of CBLB612 following single administration for neutropenia prophylaxis in breast cancer patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One injection of CBLB612 after Сhemo | Experimental | One injection of placebo at Day -2 (48 hours prior AC chemotherapy treatment) and one injection of 4 μg CBLB612 at Day 1 (24 hours after AC chemotherapy treatment) |
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| One injection of CBLB612 prior Сhemo | Experimental | One injection of 4 μg CBLB612 at Day -2 (48 hours prior AC chemotherapy treatment) and one injection of placebo at Day 1 (24 hours after AC chemotherapy treatment) |
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| Placebo | Placebo Comparator | Two injections of placebo at Day -2 and Day 1 (48 hours prior and 24 hours after AC chemotherapy treatment) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBLB612 | Drug | 4 μg CBLB612 SQ |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of ANC <1.0 x 103/μl (Grade 3-4) | Baseline to up to 38 days after the 1st drug administration | |
| Duration of ANC <0.5 x 103/μl (Grade 4) | Baseline to up to 38 days after the 1st drug administration | |
| Maximum level of ANC decrease (nadir) | Baseline to up to 38 days after the 1st drug administration | |
| Time to recovery of ANC level ≥1.5 x 103/μl | Baseline to up to 38 days after the 1st drug administration | |
| Incidence of febrile neutropenia (simultaneous drop of ANC <0.5 x 103/μl and body temperature >38.0°C) | Baseline to up to 38 days after the 1st drug administration | |
| Safety evaluation as measured by treatment-related adverse events as assessed by CTCAE v4.0 | Baseline to up to 38 days after the 1st drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of thrombocytopenia <50 x 103/μl | Baseline to up to 38 days after the 1st drug administration | |
| Duration of thrombocytopenia <25 x 103/μl | Baseline to up to 38 days after the 1st drug administration |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergei A. Tiuliandin, MD PhD | Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences | Principal Investigator |
| Aleksei G. Manikhas, MD PhD | St.-Petersburg State Budgetary Healtcare Institution "City Clinical Oncological Dispensary" | Principal Investigator |
| Dmitrii A. Krasnozhon, MD PhD | State Budgetary Healtcare Institution "Leningrad Region Oncological Dispensary" | Principal Investigator |
| Ruslan M. Paltuev, MD PhD | Non-State Healtcare Institution "Road Clinical Hospital of Open Joint Stock Company Russian Railways" | Principal Investigator |
| Natalia V. Fadeeva, MD PhD | Federal State Budgetary Healtcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary" | Principal Investigator |
| Roman S. Ponomarev, MD PhD | State Region Budgetary Healtcare Institution "Murmansk Region Oncological Dispensary" | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo | Drug |
|
|
| Duration of thrombocytopenia <10 x 103/μl | Baseline to up to 38 days after the 1st drug administration |
| Maximum decrease of platelet level (nadir) | Baseline to up to 38 days after the 1st drug administration |
| Time to platelet level recovery ≥75 x 103/μl | Baseline to up to 38 days after the 1st drug administration |
| Changes in comparison with baseline level CD34+ by FACS | Baseline to up to 11 days after the 1st drug administration |
| Changes in comparison with baseline level absolute reticulocyte count | Baseline to up to 24 days after 1st the drug administration |
| Change of concentration of G-CSF by ELISA | Baseline to up to 11 days after the 1st drug administration |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |