Recruiting NCT06456528
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL0911, QL0911 plus Placebo, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer Treatment-Induced Thrombocytopenia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
Overview
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.
Interventions
- Drug QL0911
QL0911 - Drug QL0911 plus Placebo
QL0911 plus Placebo - Drug Placebo
Placebo
Primary outcome measures
- The proportion of treatment responders. [Time frame: Randomization up to 80 days]
Secondary outcome measures (3)
- Duration from the commencement of treatment to a platelet count ≥100×109/L [Time frame: Randomization up to 30 days]
- Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy [Time frame: Randomization up to 150 days]
- Number of adverse events (AEs)/serious adverse events (SAEs) [Time frame: Randomization up to 150 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Harbin First Hospital — Harbin
- Nanjing Tianyinshan Hospital — Nanjing
Identifiers
NCT: NCT06456528 · QL0911-302