QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Treatment-Induced Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QL0911

Group Type EXPERIMENTAL

QL0911

Intervention Type DRUG

QL0911

QL0911 plus Placebo

Group Type EXPERIMENTAL

QL0911 plus Placebo

Intervention Type DRUG

QL0911 plus Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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QL0911

Intervention Type DRUG

QL0911 plus Placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No