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Chemotherapy-Induced NeutropeniaPhase 2MyeloConceptNCT02692742

Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia

A Phase 2 study testing Myelo001 in people with Chemotherapy-Induced Neutropenia and Myelosuppression, run by Myelo Therapeutics GmbH at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses and density of chemotherapy that can be tolerated. The degree and duration of neutropenia determine the risk of infection. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Myelo001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
23 sitesGermany
Study dates
Mar 2016to Nov 2017
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • Echocardiography: No contraindication for the scheduled chemotherapy
  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Site 20

    Aachen

  • Site 16

    Aurich

  • Site 21

    Dresden

  • Site 26

    Dresden

  • Site 05

    Erlangen

  • Site 09

    Esslingen am Neckar

  • Site 02

    Frankfurt a.M.

  • Site 13

    Frankfurt a.M.

  • Site 01

    Friedrichshafen

  • Site 25

    Goslar

  • Site 11

    Hamburg

  • Site 10

    Hanover

  • Site 22

    Hanover

  • Site 07

    Konstanz

  • Site 29

    Lübeck

  • Site 03

    Mainz

  • Site 23

    Mainz

  • Site 04

    Offenbach

  • Site 19

    Oldenburg

  • Site 17

    Ravensburg

  • Site 24

    Rosenheim

  • Site 28

    Tübingen

  • Site 12

    Westerstede

Other trials in Germany

About this study

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

Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses and density of chemotherapy that can be tolerated. The degree and duration of neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule, has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate differentiation of peripheral white blood cells (WBC) and bone marrow cells of the leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is to determine the safety and effectiveness of Myelo001 in preventing or reducing chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due to breast cancer.

Read the detailed description

Phase IIa study, 1:1 randomized, double-blind, placebo-controlled, parallel-design, multi-center study. Each breast cancer patient will be randomly assigned into one of two treatment arms receiving either Myelo001 or placebo as a tablet. Investigational medicinal product is taken as supportive care for 23 consecutive days during chemotherapy treatment. Hematologic and safety parameters as well as actual begin and doses of following chemotherapy cycles will be assessed. A single primary variable will be analyzed with test statistics based on frequent absolute neutrophil measurements. Additionally, in a subgroup of patients biomarkers and pharmacokinetics of Myelo001 will be investigated.

Being tested
Myelo001, Placebo
Keywords
Chemotherapy, Chemotherapy-induced Neutropenia, Supportive Care, Myelosuppression, CIN
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myelo001Drug

    Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

  • PlaceboDrug

    Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Study groups in NCT02692742
Study groupRoleWhat they receive
Myelo001ExperimentalMyelo001 100 mg QD
Receives: Drug: Myelo001
PlaceboPlacebo comparatorMatching Placebo QD
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: visit 3 to visit 10 (22 days)

  2. 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

    Measured: visit 3 to visit 10 (22 days)

  3. Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia

    Measured: visit 3 to visit 10 (22 days)

Secondary outcomes (15)

  1. Treatment success rate: a) Neutropenia grade ≤2, b) No need for G-CSF rescue therapy, c) No early withdrawal (drop-out).

    Measured: visit 3 to visit 10 (22 days)

  2. 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

    Measured: visit 3 to visit 10 (22 days)

  3. Change of Threshold Area over the Curve of lymphocytes

    Measured: visit 3 to visit 10 (22 days)

  4. Change of Threshold Area over the Curve of leukocytes

    Measured: visit 3 to visit 10 (22 days)

  5. Change of Threshold Area over the Curve of thrombocytes

    Measured: visit 3 to visit 10 (22 days)

  6. Proportion of patients with neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L

    Measured: visit 3 to visit 10 (22 days)

  7. Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L

    Measured: visit 3 to visit 10 (22 days)

  8. ANC at nadir

    Measured: visit 3 to visit 10 (22 days)

  9. Time to ANC nadir (from start of chemotherapy)

    Measured: visit 3 to visit 10 (22 days)

  10. 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)

    Measured: visit 3 to visit 10 (22 days)

  11. 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)

    Measured: visit 3 to visit 10 (22 days)

  12. 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)

    Measured: visit 3 to visit 10 (22 days)

  13. Proportion of patients with rescue therapy

    Measured: visit 3 to visit 10 (22 days)

  14. 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)

    Measured: visit 3 to visit 10 (22 days)

  15. Proportion of patients with CTX dose reduction and/or delay of CTX cycle 2

    Measured: visit 10 to visit 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02692742
Sponsor's protocol ID
CT-MT001-2-2015-1
Other IDs
2015-003610-25, 2015
Acronym
MyeloConcept
Status last verified
Nov 2017
First submitted
23 Feb 2016
Last updated
24 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Myelo001 in people with Chemotherapy-Induced Neutropenia and Myelosuppression, run by Myelo Therapeutics GmbH at 23 sites in Germany.

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 15 inclusion and 14 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. 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. Some participants in this study may receive a placebo. 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 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?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02692742.

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 24 Nov 2017.

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