Romiplostim N01 to treat chemotherapy-related low platelets

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 2 trial of Romiplostim N01 in adults with chemotherapy-induced thrombocytopenia who remained refractory after repeated treatment with recombinant human thrombopoietin (rhTPO) or interleukin-11 (IL-11). Eligible patients have platelet counts below 30×10^9/L for more than one month and have stopped chemo/radiotherapy for at least one month. Investigators will give Romiplostim N01 and monitor platelet counts from week 1 through week 24, with weekly safety visits during a 4-week safety period and ongoing adverse event surveillance. Outcomes will be compared against contemporaneous or historical patients receiving supportive care or eltrombopag.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18 years or above, gender not restricted;
* Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10\^9/L, defined as refractory CTIT);
* Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
* Patients with platelet count at enrollment \< 30×10\^9/L;
* Patients with platelet count remains \< 30×10\^9/L for more than 1 month;
* Patients with expected survival period ≥ 6 months;
* Patients with liver and kidney function \< 1.5× upper limit of normal value, physical examination qualified;
* Patients with ECOG physical status score ≤ 2 points;
* Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;
* Patients who is voluntary to sign the informed consent form;

Exclusion Criteria:

* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
* Patients with poor compliance;
* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
* Patients with sepsis or patients with other irregular bleeding；
* Patients taking antiplatelet drugs at the same time；
* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
* Researchers believe that patients should not participate in the test of any other condition.

Where it's running

• Chinese Academy of Medical Science and Blood Disease Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Yunfei Chen, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Ting Sun, MD
• Email: sunting@ihcams.ac.cn
• Phone: +8615822339131

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Romiplostim N01 plus ATRA for persistent chemotherapy-induced low platelets after remission from gynecologic, breast, or lung cancer

  This trial tests whether adding ATRA to Romiplostim N01 helps people keep a safe platelet count after finishing chemotherapy for certain cancers.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07586826

• Romiplostim N01 plus ATRA for persistent low platelets after cancer remission

  This study tests whether adding all-trans retinoic acid to Romiplostim N01 helps people who still have low platelets after GI/digestive system cancer remission reach safer platelet levels.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07586813

• Romiplostim to prevent chemotherapy-related low platelets in Ewing sarcoma

  This trial will test whether giving romiplostim during interval-compressed chemotherapy can reduce episodes of low platelets in people with newly diagnosed Ewing sarcoma.

  Recruiting at 2 sites Early Phase 1 Children's Hospital Medical Center, Cincinnati · Phoenix, Arizona and 1 other locations · NCT07048249

• Romiplostim N01 for chemotherapy-related low platelets in children and young adults

  Romiplostim N01 will be tried to raise platelet counts in children and young adults (ages 6–24) who develop low platelets after chemotherapy for solid tumors or blood cancers.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07043894

• Home monitoring of blood tests for cancer patients

  This study is testing if cancer patients can do their blood tests at home during chemotherapy to make things easier and improve their care.

  Recruiting at 5 sites Pomeranian Medical University Szczecin · Næstved, Region Sjælland and 4 other locations · NCT06809101

• Using Herombopag to treat low platelet counts from chemotherapy

  This study is testing if a new medication called Herombopag can help increase low platelet counts in patients who have not responded well to other treatments after chemotherapy.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT05236582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.