A Phase 2 interventional study of ANF-RHO™ and Neulasta® in Chemotherapy-induced Neutropenia, sponsored by Prolong Pharmaceuticals. Terminated at 8 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Prolong Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 21 studies in Neutropenia with a site in France — 3 open to participants now, 4 under way, 1 of them phase 3. Neutropenia · France.
Among the 21 studies in Neutropenia with a site in France, this one is the 16th largest by enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2017, is one of 5 in phase 2, and was the 15th registered.
316 studies on the registry are indexed under Neutropenia; 42 are open to participants now.
Browse Neutropenia studies →3 of the 21 studies in Neutropenia with a site in France are open now. Recruiting first, the newest first:
X4 Pharmaceuticals · Sites in France, United States, Argentina and 22 more countries
Ages 12+
University Hospital, Strasbourg, France · Sites in France
Ages 65+
GERCOR - Multidisciplinary Oncology Cooperative Group · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 24 Neutropenia studies recruiting now, 12 (50%) set no upper age limit and 12 (50%) stop at 75 or younger; 11 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 82 across 230 interventional studies indexed under Neutropenia.
Median enrollment 145 across the 16 interventional studies, 120 across the 5 observational. Of the 17 that completed or were terminated, 3 (18%) have results posted.
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5 of 21 have an industry lead sponsor. The 10 most frequent:
Prolong Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Prolong Pharmaceuticals has 1 study filed under Neutropenia — fewer than ten, so there is no comparison to draw.
1 of the studies in Neutropenia with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06056297Phase 3X4 PharmaceuticalsA Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections | 2027-09 |
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Among the 21 studies in Neutropenia with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Forty Eight (48) adult female, chemotherapy treatment-naïve, stage I to III, breast cancer patients scheduled to receive FEC100 (3 cycles)/docetaxel (3 cycles) myelosuppressive chemotherapy will be enrolled into the study after they meet all the inclusion/exclusion criteria. Four (4) Cohorts of 12 patients each will be studied; they will be randomized either in the ANF-RHO™ treatment arm at different doses (10 μg/kg, 20 μg/kg, or 30 μg/kg, for the cohorts 1-3, respectively) or Neulasta® (6 mg / 0.6 ml SC injection, for cohort 4). For the cohorts 1-3, 12 patients from each of the respective ANF-RHO™ cohorts will be randomized with four patients from cohort 4 (Neulasta®). Patients in the ANF-RHO™ cohorts will receive study drug on Day 1 of each Chemotherapy cycle. Patients in the Neulasta® cohort will receive study drug on Day 2 of each Chemotherapy cycle. Doses of ANF-RHO™/Neulasta® will be provided for a total of 6 cycles (21 days each). The total duration of the study 129 ± 2 days (126 Days of treatment period followed by end of study visit)
Inclusion Criteria:
Scheduled to receive and anticipated to complete the following chemotherapy regimen
Exclusion Criteria: A subject will not be enrolled if any they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg as a subcutaneous injection.
Drug: ANF-RHO™
Neulasta® will be administered to the subjects at a dose of 6.0 mg in 0.6 ml as a subcutaneous injection.
Drug: Neulasta®
Subjects randomized to the ANF-RHO™ treatment arm will receive the investigational product on Day 1(day of chemotherapy treatment) of each Chemotherapy cycle. ANF-RHO™ will be administered to the subjects as a subcutaneous injection. Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg. ANF-RHO™ is provided as a single-use glass vial containing 1.0 ml of solution at a concentration of 5 mg/ml
Also known as: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)
Subjects randomized to the Neulasta® treatment arm will receive the comparator drug on Day 2(day after chemotherapy treatment) of each Chemotherapy cycle. Neulasta® will be administered to the subjects at a standard dose of 6.0 mg in 0.6 ml as a subcutaneous injection. Neulasta® is also provided as a single-use pre-filled syringe.
Also known as: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).
Time frame: 21 days
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the fourth cycle of chemotherapy (docetaxel).
Time frame: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the first chemotherapy cycle (21-day cycle FE100C)
Time frame: 21 days
Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)
Time frame: 21 days
Incidence of severe neutropenia (ANC < 0.5 x 10^9/L) during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of febrile neutropenia defined as peak temperature ≥38.0°C for two readings over two hours and ANC < 0.5 x 10^9/L, during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on use of antibiotics during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of infection and infection-related events based on the need for hospitalization during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of moderate (ANC ≥ 50 x 10^9/L) leukocytosis during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Incidence and duration of severe (ANC ≥ 100 x 10^9/L) leukocytosis during all chemotherapy cycles
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Blood pressure
Assessment of Blood pressure (systolic and diastolic) helps determine the safety of the medications under study - ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Heart rate
Assessment of Heart rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Respiratory rate
Assessment of Respiratory rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Clinically meaningful changes in vital signs during all chemotherapy cycles - Assessment of Body Temperature
Assessment of Respiratory rate helps determine the safety of the medications under study - ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Incidence of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Duration of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Severity of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Site of bone pain, determined by a numerical rating scale, as well as other reported adverse events
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Maximum Plasma Concentration (Cmax)
Cmax is the maximum concentration of the drug (either ANF-RHO or Neulasta) that is achieved after administration of a dose
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of Time taken to reach the maximum concentration (Tmax)
Tmax is the time taken to reach the maximum concentration (Cmax) after administration of a dose.
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Measurement of half-life (T1/2)
T1/2 is the time taken for ANF-RHO and Neulasta to reach half the value of their initial concentrations. T1/2 determination helps in understanding the duration for which ANF-RHO or Neulasta would be active upon administration.
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t])
AUC\[0-t\] is an important parameter for determining as to how much of the drug is available in the body after administration of a drug formulation, in this case ANF-RHO vs Neulasta. Understanding the AUC for both these drug formulations will help us to determine the efficacy and safety profiles of these medicines.
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-∞])
Similar to AUC\[0-t\] which is estimated till time 't', in AUC\[0-∞\], the estimation is done on the concentration of the drug to an infinite time. Calculation of the AUC\[0-∞\], helps understand how much of the drug is available in the body at extremely low concentrations, beyond the limits of measurable concentrations.
Time frame: ~ 128 ± 2 days
Pharmacokinetic profile of ANF-RHO and Neulasta - Area Under the Curve (AUC[0-t]/AUC[0-∞])
The parameter AUC\[0-t\]/AUC\[0-∞\] is useful to calculate the fraction of the Total AUC that was added due to the extrapolated AUC (AUC\[0-∞\]). It helps understand if the methods employed for determining the total AUC and drug's availability in the body are correct.
Time frame: ~ 128 ± 2 days
Incidence of anti-drug antibodies to ANF-RHO and Neulasta
Time frame: ~ 128 ± 2 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Apr 2018, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Prolong Pharmaceuticals