QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Cancer Treatment-Induced Thrombocytopenia

Treatments: Drug: QL0911 plus Placebo; Drug: Placebo; Drug: QL0911

Study type: Interventional

Funder types: Industry

Identifiers

NCT06456528

QL0911-302

Details and patient eligibility

About

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

Enrollment: 235 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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235 participants in 3 patient groups, including a placebo group

QL0911

Experimental group

Treatment:

Drug: QL0911

QL0911 plus Placebo

Experimental group

Treatment:

Drug: QL0911 plus Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo