QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

January 8, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

235

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Harbin, China
        • Recruiting
        • Harbin First Hospital
        • Contact:
      • Nanjing, China
        • Recruiting
        • Nanjing Tianyinshan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: QL0911
Drug: QL0911
QL0911
Experimental: QL0911 plus Placebo
Drug: QL0911 plus Placebo
QL0911 plus Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of treatment responders.
Time Frame: Randomization up to 80 days
Randomization up to 80 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration from the commencement of treatment to a platelet count ≥100×109/L
Time Frame: Randomization up to 30 days
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
Randomization up to 150 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: Randomization up to 150 days
Randomization up to 150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL0911-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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