Cancer Treatment-Induced ThrombocytopeniaPhase 2/3NCT06456528
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
A Phase 2/3 study testing QL0911 in people with Cancer Treatment-Induced Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Treatment-Induced Thrombocytopenia
- What is being tested?
- QL0911
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 2 sitesChina
- Study dates
- 22 Oct 2024to 30 Jul 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Harbin First Hospital
Harbin
Chief Physician, +86-0451-84883471, majun0322@126.com
- Recruiting
Nanjing Tianyinshan Hospital
Nanjing
Chief Physician, +86-025-84453932, qinsk81@163.com
About this study
Official title: 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.
- Being tested
- QL0911, QL0911 plus Placebo, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0911Drug
QL0911
QL0911 plus PlaceboDrug
QL0911 plus Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| QL0911 | Experimental | Not described Receives: Drug: QL0911 |
| QL0911 plus Placebo | Experimental | Not described Receives: Drug: QL0911 plus Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of treatment responders.
Measured: Randomization up to 80 days
Secondary outcomes (3)
Duration from the commencement of treatment to a platelet count ≥100×109/L
Measured: Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy
Measured: Randomization up to 150 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Measured: Randomization up to 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start22 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Treatment-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456528
- Sponsor's protocol ID
- QL0911-302
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
- ClinicalTrials.gov ID
- NCT06456528
- Acronym / sponsor ID
- QL0911-302
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QL0911 | Experimental | Drug: QL0911 |
| QL0911 plus Placebo | Experimental | Drug: QL0911 plus Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL0911QL0911 | Drug | QL0911 |
| QL0911 plus PlaceboQL0911 plus Placebo | Drug | QL0911 plus Placebo |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The proportion of treatment responders.
Time frame: Randomization up to 80 days
3 secondary outcomes
Duration from the commencement of treatment to a platelet count ≥100×109/L
Time frame: 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
Number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Randomization up to 150 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QL0911 in people with Cancer Treatment-Induced Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Ma (0451-84883471, majun0322@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of treatment responders. (time frame: Randomization up to 80 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.