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Trial Title:
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
NCT ID:
NCT06456528
Condition:
Cancer Treatment-Induced Thrombocytopenia
Conditions: Official terms:
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
QL0911
Description:
QL0911
Arm group label:
QL0911
Intervention type:
Drug
Intervention name:
QL0911 plus Placebo
Description:
QL0911 plus Placebo
Arm group label:
QL0911 plus Placebo
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06456528
