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Recruiting

NCT Number: NCT06456528

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Harbin First Hospital, Harbin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QL0911

Drug

QL0911

QL0911 plus Placebo

Drug

QL0911 plus Placebo

Placebo

Drug

Placebo

Primary outcomes

  1. The proportion of treatment responders.

    Time frame: Randomization up to 80 days

Secondary outcomes

  1. Duration from the commencement of treatment to a platelet count ≥100×109/L

    Time frame: Randomization up to 30 days

  2. Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy

    Time frame: Randomization up to 150 days

  3. Number of adverse events (AEs)/serious adverse events (SAEs)

    Time frame: Randomization up to 150 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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