Health TrialsbyHealthPanel

QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

ConditionCancer Treatment-Induced Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • QL0911

    Drug

    QL0911

  • QL0911 plus Placebo

    Drug

    QL0911 plus Placebo

  • Placebo

    Drug

    Placebo

Treatment groups

235 Participants
are divided into 3 treatment groups
Group A: QL0911Experimental treatment 1 intervention
Group B: QL0911 plus PlaceboExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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