A Phase 2 interventional study of Albipagrastim alf in Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN) and Neutropenia, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Prevention
Among 20 studies in Febrile Neutropenia with a site in China — 8 open to participants now, 8 under way, none of them phase 3. Febrile Neutropenia · China.
Among the 20 studies in Febrile Neutropenia with a site in China, this one is the 17th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2026, is one of 8 in phase 2, and was the 19th registered.
147 studies on the registry are indexed under Febrile Neutropenia; 36 are open to participants now.
This study's planned enrollment of 18 is below the median of 120 across 95 interventional studies indexed under Febrile Neutropenia.
Browse Febrile Neutropenia studies →8 of the 20 studies in Febrile Neutropenia with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 19 Febrile Neutropenia studies recruiting now, 11 (58%) set no upper age limit and 8 (42%) stop at 75 or younger; 4 take children under 18; 0 take healthy volunteers.
This study: 0 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2026.
Median enrollment 150 across the 17 interventional studies, 200 across the 3 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
9 of 20 have an industry lead sponsor. The 10 most frequent:
Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 198 studies on the registry; 120 are open to participants now.
Qilu Pharmaceutical Co., Ltd. has 2 studies filed under Febrile Neutropenia — fewer than ten, so there is no comparison to draw.
3 of the studies in Febrile Neutropenia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07899099Zheng YabingMecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer | 2026-12-31 |
| NCT07724756Qilu Pharmaceutical Co., Ltd.Phase II Study of QLC2519 in Pediatric Solid Tumor Participants | 2027-06-26 |
| NCT07204522Shanxi Bethune HospitalEfficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients. | 2027-09-22 |
Among the 20 studies in Febrile Neutropenia with a site in China, from their registry updates:
QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA. The modified G-CSF retained high activity while reducing affinity for the G-CSF receptor, which can significantly inhibit the the G-CSF receptor-mediated (RMC) pathway. The aim of this study is to evaluate the PK/PD characteristics of QLC2519 in preventing chemotherapy-induced neutropenia (CIN) in children with sarcoma.
This study is a multicenter, open lable Phase II study planed to enroll 18 children with pediatric sarcoma. The participants will receive the VDC/IE chemotherapy regimen (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide) and will be scheduled to undergo 3 chemotherapy cycles (21 days per cycle). The participants will be stratified by age (\<6 years, 6 to \<12 years, 12 to \<18 years), with enrollment progressing from the older to the younger age groups (6 in each group).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion 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.
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).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Chemotherapy C1\&3: Changchun Shinkai (V): 1.5 mg/m² (maximum dose 2 mg), iv, on D1, 8, and 15; Doxorubicin (D): 30 mg/m², iv over more than 6 hours, on D1 and 2; Cyclophosphamide (C): 1.2 g/m², iv over more than 1 hour, on D1; Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, and 9 hours during cyclophosphamide. Chemotherapy C2: Ifosfamide (I): 1.8 g/m², iv over more than 1 hour, QD for 5 days (D1\~D5); Etoposide (E): 100 mg/m², iv over more than 4 hours, QD for 5 days (D1\~D5); Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, 9 hours during ifosfamide.
Drug: Albipagrastim alf
QLC2519 500 μg/kg was administered 48 hours after chemotherapy (generally on D4 of the first and third chemotherapy cycles, and on D7 of the second cycle, between 6:00 and 10:00 AM), once per chemotherapy cycle.
Cmax of QLC2519
Maximum (peak) serum concentration (Cmax) of QLC2519 will be reported.
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
AUC0-t of QLC2519
Area Under the Curve from time zero to time t (AUC0-t) of QLC2519 will be reported.
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count (ANC)
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
Duration and incidence of severe ANC reduction
ANC \< 0.5 × 10⁹/L
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Efficacy: Incidence of febrile neutropenia (FN)
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Duration and incidence of ANC < 1.0 × 10^9/L
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 14
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Qilu Pharmaceutical Co., Ltd. →