Chemotherapy-Induced ThrombocytopeniaPhase 2NCT05969158
Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma
A Phase 2 study testing Hetrombopag in people with Chemotherapy-Induced Thrombocytopenia, run by Sun Yat-sen University.
Trial summary
To explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy-Induced Thrombocytopenia
- What is being tested?
- Hetrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2023to 1 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old, gender is not limited;
- Lymphoma was confirmed by histopathological or cytological examination;
- The patient needs to receive Selinexor combined chemotherapy containing XPO-1 inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not limited to the above schemes;
- Patients who do not routinely undergo preventive platelet elevation therapy after the above treatment can receive salvage therapeutic platelet elevation therapy only when the PLT is < 50×109/L;
- Patients with the lowest platelet value < 50×109/L after the previous course of treatment.
- The patient's laboratory examination meets the following criteria:
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- Adequate bone marrow function at Screening: absolute count of blood neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥90g/L; (2) Liver function: Without liver metastasis, serum total bilirubin (TBIL) ≤ upper limit of normal (ULN) ×1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN×3; With liver metastasis, TBIL≤ upper limit of normal (ULN) ×3, ALT, AST≤ULN×5; (3) Kidney function: creatinine (Cr) ≤1.5×ULN; (4) Coagulation function: International standardized ratio (INR) of prothrombin time (PT) ≤ULN×1.5;
- 7. Able to take oral medications;
- 8. Patients voluntarily sign informed consent;
- 9. Survival is expected to be ≥12 weeks at the time of screening, and can be treated with the current chemotherapy regimen for at least 2 cycles;
- 10. Subjects of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive support, abstinence from sex, and insertion of an IUD); Excluding female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, and male subjects who have undergone bilateral vasectomy or ligation.
Who cannot join
- Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to hypersplenism, infection, and bleeding (including severe visceral or intracranial bleeding), occurred within 6 months before screening;
- A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple myeloma;
- Any history of arterial or venous thrombosis in the 3 months prior to screening;
- Patients had clinical manifestations of severe bleeding (such as gastrointestinal bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT > 400×109/L;
- The subject has an allergic reaction to hetrombopag or any of its excipients;
- Serious cardiovascular disease (such as NYHA heart function) in the 6 months prior to screening Score Ⅲ-Ⅳ), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, after coronary stenting, angioplasty, and coronary artery bypass grafting;
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- The subjects participated in other clinical studies of similar platelet enhancing drugs within 30 days prior to screening;
- As assessed by the investigator, the subject has any concomitant medical history that could impair the subject's safe completion of the study, such as unstable angina pectoris, renal failure on hemodialysis, or active infection requiring intravenous antibiotics;
- Subjects who are pregnant or breastfeeding, or who cannot use contraception during the trial;
- Other circumstances in which the investigator considers the subject unsuitable for participation in the study;
- HIV infected persons;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open, Single-center, Phase II Clinical Study of Hetrombopag in Secondary Prevention of XPO-1 Inhibitor Selinexor Combined With Chemotherapy Induced Thrombocytopenia in Lymphoma
To explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma.
Read the detailed description
To investigate the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined with chemotherapy.
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Being tested
- Hetrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
Also called SHR8735
After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria.
The platelet reduction after the previous chemotherapy was used as the control group:
The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT < 50×109/L.
Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group:
The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5).
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag | Experimental | Hetrombopag 5mg/d Receives: Drug: Hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
Measured: Five days before and five days after chemotherapy
Secondary outcomes (5)
The minimum and maximum values of median platelets before and after secondary prevention.
The minimum and maximum values of median platelets before and after secondary prevention.
Measured: 2-3 months
The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
Measured: 2-3 months
The time required for platelet recovery to 100×109/L and 75×109/L;
The time required for platelet recovery to 100×109/L and 75×109/L;
Measured: 2-3 months
The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
Measured: 2-3 months
The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Sep 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Zhiming Li, MD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969158
- Sponsor's protocol ID
- B2023-056-01
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-center, Phase II Clinical Study of Hetrombopag in Secondary Prevention of XPO-1 Inhibitor Selinexor Combined With Chemotherapy Induced Thrombocytopenia in Lymphoma
- ClinicalTrials.gov ID
- NCT05969158
- Acronym / sponsor ID
- B2023-056-01
- Conditions
- Chemotherapy-Induced Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Aug 2023 (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 explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma.
Detailed description
To investigate the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag | Experimental | Drug: HetrombopagHetrombopag 5mg/d |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 70 years old, gender is not limited;
- Lymphoma was confirmed by histopathological or cytological examination;
- The patient needs to receive Selinexor combined chemotherapy containing XPO-1 inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not limited to the above schemes;
- Patients who do not routinely undergo preventive platelet elevation therapy after the above treatment can receive salvage therapeutic platelet elevation therapy only when the PLT is < 50×109/L;
- Patients with the lowest platelet value < 50×109/L after the previous course of treatment.
Key exclusion criteria (11 listed)
- Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to hypersplenism, infection, and bleeding (including severe visceral or intracranial bleeding), occurred within 6 months before screening;
- A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple myeloma;
- Any history of arterial or venous thrombosis in the 3 months prior to screening;
- Patients had clinical manifestations of severe bleeding (such as gastrointestinal bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT > 400×109/L;
- The subject has an allergic reaction to hetrombopag or any of its excipients;
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 |
|---|---|---|
| HetrombopagAlso: SHR8735After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria. The platelet reduction after the previous chemotherapy was used as the control group: The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT < 50×109/L. Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group: The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5). | Drug | Hetrombopag |
Primary outcome
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
Time frame: Five days before and five days after chemotherapy
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
5 secondary outcomes
The minimum and maximum values of median platelets before and after secondary prevention.
Time frame: 2-3 months
The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
Time frame: 2-3 months
The time required for platelet recovery to 100×109/L and 75×109/L;
Time frame: 2-3 months
The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
Time frame: 2-3 months
The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhiming Li, MD. principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hetrombopag in people with Chemotherapy-Induced Thrombocytopenia, run by Sun Yat-sen University.
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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Li, MD. (+86-13719189172, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment. (time frame: Five days before and five days after chemotherapy). 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 6 Sep 2023.