QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
1 other identifier
interventional
235
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 12, 2026
January 1, 2026
1.7 years
June 7, 2024
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of treatment responders.
Randomization up to 80 days
Secondary Outcomes (3)
Duration from the commencement of treatment to a platelet count ≥100×109/L
Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy
Randomization up to 150 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Randomization up to 150 days
Study Arms (3)
QL0911
EXPERIMENTALQL0911 plus Placebo
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Harbin First Hospital
Harbin, China
Nanjing Tianyinshan Hospital
Nanjing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 13, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01