A Phase 2 interventional study of Romiplostim N01 in Cancer Treatment-induced Thrombocytopenia (CTIT), sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Anhui Provincial Hospital · Phase 2, Interventional, and Treatment
Among 41 studies testing romiplostim in Thrombocytopenia — 9 open to participants now, 9 under way, 3 of them phase 3. romiplostim · Thrombocytopenia.
Among the 41 studies testing romiplostim in Thrombocytopenia, this one is the 10th largest by planned enrollment, is one of 4 that started in 2025, is one of 20 in phase 2, and was the 36th registered.
482 studies on the registry are indexed under Thrombocytopenia; 100 are open to participants now.
Browse Thrombocytopenia studies →9 of the 41 studies testing romiplostim in Thrombocytopenia are open now, in 3 countries. Recruiting first, the newest first:
Nantes University Hospital · Sites in France
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ain Shams University · Sites in Egypt
The First Affiliated Hospital of Henan University of Science and Technology · Sites in China
By country, each count listing its studies:
romiplostim: first FDA approval 2008 (NPLATE), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 66 Thrombocytopenia studies recruiting now, 44 (67%) set no upper age limit and 18 (27%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 24 · Phase 3 13 · Phase 4 1
First in 2002; this study’s year is marked. 4 started in 2025.
This study's planned enrollment of 97 is above the median of 54 across 334 interventional studies indexed under Thrombocytopenia.
Median enrollment 62 across the 41 interventional studies. Of the 29 that completed or were terminated, 20 (69%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 41 have an industry lead sponsor. The 10 most frequent:
Anhui Provincial Hospital is the lead sponsor of 135 studies on the registry; 101 are open to participants now.
Anhui Provincial Hospital has 4 studies filed under Thrombocytopenia — fewer than ten, so there is no comparison to draw.
1 of the studies testing romiplostim in Thrombocytopenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06898983Anhui Provincial HospitalEfficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia | 2027-01-31 |
Among the 41 studies testing romiplostim in Thrombocytopenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia
Cancer treatment-induced thrombocytopenia (CTIT) refers to a decrease in platelet count caused by antitumor therapies during cancer treatment. It is a common adverse effect of anticancer treatment, with a particularly high incidence in patients with hematologic malignancies. CTIT increases the risk of bleeding, may limit treatment options, and can ultimately compromise the effectiveness of cancer therapy and reduce long-term survival. Currently, aside from platelet transfusion, thrombopoietic agents are commonly used to manage CTIT. Studies have shown that Romiplostim demonstrates a response rate of up to 71% in patients with chemotherapy-induced thrombocytopenia from solid tumors, with 89% of patients avoiding the need for platelet transfusion, thereby significantly reducing the risk of bleeding. However, there is limited evidence and a lack of prospective clinical trials investigating the use of Romiplostim in leukemia patients with CTIT. This study aims to evaluate the efficacy and safety of Romiplostim in adult leukemia patients with CTIT, in order to provide new therapeutic options and strategies, and ultimately improve the quality of life for this patient population.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
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.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Romiplostim N01 will be administered once weekly via subcutaneous injection upon the occurrence of Grade 3 thrombocytopenia (platelet count \< 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. A maximum of 8 doses may be administered during the treatment period.
Drug: Romiplostim N01
Romiplostim N01 will be administered via subcutaneous injection once weekly when patients develop Grade 3 thrombocytopenia (platelet count \< 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. Treatment may continue for up to 8 doses.
Platelet response at Week 2 (PLT ≥ 50×10⁹/L)
Proportion of patients achieving a platelet count ≥ 50×10⁹/L at 2 weeks after initiation of treatment.
Time frame: 2 weeks
Early Platelet Response Rate (within 7 days)
Proportion of patients achieving a response within 7 days of treatment initiation (Response defined as: no requirement for platelet transfusion and either a platelet count increase to ≥ 50×10⁹/L, at least a two-fold increase from baseline, or a platelet count ≥ 100×10⁹/L.)
Time frame: 7 days
Median time to platelet recovery without transfusion
Median time to achieve platelet counts of ≥ 50×10⁹/L and ≥ 100×10⁹/L without platelet transfusion.
Time frame: 8 weeks
Total platelet transfusion during treatment
Total platelet transfusion during treatment
Time frame: 8 weeks
Platelet nadir during treatment
Nadir platelet count during the treatment period (from initiation to end of treatment)
Time frame: 8 weeks
Incidence of adverse events
Incidence of adverse events
Time frame: Within 28 days after treatment discontinuation
Incidence of bleeding events
Incidence of bleeding events (based on World Health Organization bleeding assessment scale)
Time frame: Within 28 days after treatment discontinuation
Survival outcomes
Relapse-Free Survival (RFS), Overall Survival (OS), and Cumulative Incidence of Relapse (CIR)
Time frame: Within 28 days after treatment discontinuation
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
Of 44 non-industry phase 2 interventional studies under Thrombocytopenia, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 83. This study's planned 18 months is below that.
Counting every sponsor, half of 54 studies reached it within 36 months; a quarter within 28 and three quarters within 81.
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.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Romiplostim