QL0911 to treat chemotherapy-related low platelet counts

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 randomized phase 2/3 interventional trial compares QL0911 against placebo (including combination/placebo arms) in adults who developed thrombocytopenia during 21-day chemotherapy cycles. Eligible participants are 18–75 years old with ECOG performance status 0–1, prior chemotherapy-induced thrombocytopenia causing treatment delay, and expected survival of at least 12 weeks. The study will monitor platelet counts, ability to maintain scheduled chemotherapy, and safety outcomes including bleeding and treatment-emergent adverse events. Patients with other hematologic disorders, active significant viral infections, or pregnancy are excluded from participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men and women, 18-75 years of age;
* Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
* Participant experienced thrombocytopenia and chemotherapy delay;
* ECOG performance status 0-1;
* The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion Criteria:

* Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
* Participant has serious bleeding symptoms;
* History of allergy to the study drug;
* Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
* Pregnant or lactating women;
* Participant has received any experimental therapy within 28 days prior to screening
* Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Where it's running

• Harbin First Hospital
  Harbin, China Recruiting
• Nanjing Tianyinshan Hospital
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Jun Ma
• Email: majun0322@126.com
• Phone: 0451-84883471

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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.