Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia (MyeloConcept)
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ClinicalTrials.gov Identifier: NCT02692742 |
Recruitment Status :
Completed
First Posted : February 26, 2016
Last Update Posted : November 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-Induced Neutropenia Myelosuppression Breast Cancer | Drug: Myelo001 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 137 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Center Study to Investigate the Efficacy To Reduce Chemotherapy-Induced Neutropenia (CIN), Effects on the Haematopoietic System, Safety and Pharmacokinetics of Myelo001 in Patients Receiving Adjuvant or Neoadjuvant Chemotherapy for the Treatment Of Breast Cancer |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
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Experimental: Myelo001
Myelo001 100 mg QD
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Drug: Myelo001
Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment |
Placebo Comparator: Placebo
Matching Placebo QD
|
Drug: Placebo
Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment |
- Threshold area over the curve (AOC1) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
- Threshold area over the curve (AOC3) of ANC: Area below the threshold line (ANC 1.0x10^9/L classified as grade 3 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
- Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia [ Time Frame: visit 3 to visit 10 (22 days) ]
- Treatment success rate: a) Neutropenia grade ≤2, b) No need for G-CSF rescue therapy, c) No early withdrawal (drop-out). [ Time Frame: visit 3 to visit 10 (22 days) ]
- Threshold AOC of ANC (AOC4): Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
- Change of Threshold Area over the Curve of lymphocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
- Change of Threshold Area over the Curve of leukocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
- Change of Threshold Area over the Curve of thrombocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
- Proportion of patients with neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L [ Time Frame: visit 3 to visit 10 (22 days) ]
- Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L [ Time Frame: visit 3 to visit 10 (22 days) ]
- ANC at nadir [ Time Frame: visit 3 to visit 10 (22 days) ]
- Time to ANC nadir (from start of chemotherapy) [ Time Frame: visit 3 to visit 10 (22 days) ]
- Time to ANC recovery from grade 3 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
- Time to ANC recovery from grade 4 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
- Time to ANC recovery from profound neutropenia (ANC ≥ 0.1x10^9/L), i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
- Proportion of patients with rescue therapy [ Time Frame: visit 3 to visit 10 (22 days) ]
- Proportion of patients developing febrile neutropenia (body temperature ≥38.3°C by single tympanic or oral measurement) and ANC ≤0.5x 10^9/L (Grade 4) [ Time Frame: visit 3 to visit 10 (22 days) ]
- Proportion of patients with CTX dose reduction and/or delay of CTX cycle 2 [ Time Frame: visit 10 to visit 11 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
- Histologically confirmed invasive breast cancer scheduled for neoadjuvant or adjuvant chemotherapy (patient with primary wound healing ([R0])
- Already selected for neoadjuvant or adjuvant standard of care EC regimen (Epirubicin 90 mg/m2 BSA (body surface area) + Cyclophosphamide 600 mg/m2 BSA q21d (every 21 days)) (with or without treatment with taxanes afterwards)
- Risk of chemotherapy-induced Febrile Neutropenia ≤20% according to ASCO Guidelines (2015)
- More than 5 days remaining before the planned initiation of the 1st chemotherapy cycle
- Performance status Grade 0-1 (ECOG)
- Echocardiography: No contraindication for the scheduled chemotherapy
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Haematologic, laboratory and chemistry thresholds at baseline:
- Absolute neutrophil count (ANC) ≥2,000 cells/ mm3 (≥2.0 x 10/L)
- Platelet count ≥100,000/mm3 (≥100 x 10exp9/L)
- Haemoglobin ≥10 g/dL
- Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)
- Serum creatinine <2.0 mg/dL
- Able to read, understand and willing to sign the informed consent form
- Able to undergo the investigations and to follow the Visit schedule
Exclusion Criteria:
- Suspected allergy to Myelo001 or its excipients
- Prior chemotherapy
- Prior or concomitant treatment with radiotherapy
- Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) during the first chemotherapy cycle
- Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF)
- Currently on or scheduled for primary prophylaxis with antibiotics in the first chemotherapy cycle
- History of bone marrow transplantation or stem cell transplant
- Administration of another investigational medicinal product / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed.
- Already confirmed HIV, hepatitis B or C virus (HBV or HCV) infection
- History of somatic disease/condition that may interfere with the objectives of the study
- Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
- Serious uncontrolled comorbidities
- Pregnant or breast-feeding subject
- Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692742

Study Director: | Dirk Pleimes, MD | Myelo Therapeutics GmbH |
Responsible Party: | Myelo Therapeutics GmbH |
ClinicalTrials.gov Identifier: | NCT02692742 |
Other Study ID Numbers: |
CT-MT001-2-2015-1 2015-003610-25 ( EudraCT Number ) |
First Posted: | February 26, 2016 Key Record Dates |
Last Update Posted: | November 24, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Chemotherapy Chemotherapy-induced Neutropenia Supportive Care Myelosuppression CIN |
Breast Neoplasms Neutropenia Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |