QL0911 to treat chemotherapy-related low platelet counts

Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.

This study will try whether QL0911 can raise platelet counts and reduce chemotherapy delays in adults who develop low platelets from cancer treatment.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Harbin and 1 other locations)
• Trial ID: NCT06456528 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 receiving 21-day chemotherapy cycles who developed chemotherapy-induced thrombocytopenia causing treatment delay, with ECOG 0–1 and expected survival ≥12 weeks are ideal candidates.

Not a fit: Patients with other hematologic diseases, active HBV/HCV/HIV infection, severe bleeding, pregnancy or lactation, allergy to the study drug, or recent experimental therapy are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, QL0911 could reduce low-platelet episodes and help patients stay on their planned chemotherapy schedule with fewer delays or dose reductions.

How similar studies have performed: Other thrombopoietin-receptor agonists have shown benefit for chemotherapy-induced thrombocytopenia in prior studies, so this therapeutic approach has precedent.

Eligibility criteria

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 this trial is running

Harbin and 1 other locations

• Harbin First Hospital — Harbin, China (RECRUITING)
• Nanjing Tianyinshan Hospital — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Jun Ma

Conditions: Cancer Treatment-Induced Thrombocytopenia