ThrombocytopeniaPhase 2/3Haplo-HSCTNCT06202625
Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
A Phase 2/3 study testing avatrombopag in people with Thrombocytopenia and Stem Cell Transplant Complications, run by Peking University People's Hospital at 14 sites in China.
Trial summary
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thrombocytopenia, Stem Cell Transplant Complications
- What is being tested?
- avatrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 14 sitesChina
- Study dates
- 13 May 2024to 30 Oct 2025
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged between 18-65 years;
- PLT<20×10^9/L or transfusion dependent on +D7 after haplo-HSCT;
- Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.
Who cannot join
- With active infection;
- ALT or AST>3ULN, or total Bil>2ULN
- Ccr<50 mL/min;
- With the history of arteriovenous thrombosis;
- With history of cardiovascular disease (such as NYHA Class III/IV congestive heart failure, arrhythmia that increases the risk of thromboembolic events [such as atrial fibrillation] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting;
- With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA;
Show all 13Show fewer
- HBsAg or anti-HCV or anti-HIV positive;
- Known to be allergic to avatrombopag and any of its excipients;
- With secondary or multiple HSCT;
- Females who were pregnant or breastfeeding or who had fertile ability but refuse to take effective contraceptive measures during and one month after this trial;
- With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
- Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition.
- Concomitant medication:The rhIL-11, rhTPO or TPO-RA(such as eltrombopag, hetrombopag and romiplostim) and desitabine, etc. were not allowed for use during this trial.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaohui Zhang, MD, zhangxiaohui@bjmu.edu.cn
Haixia Fu, MD, 13581830157, fuhaixia_210@163.com
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Yajing Xu
- Not yet recruiting
Xinqiao Hospital, Army Military Medical University
Chongqing, Sichuan
Xi Zhang
- Not yet recruiting
Guangzhou First People's Hospital, School of Medicine, South China University of Technology
Guangzhou, Guangdong
Shunqing Wang
- Not yet recruiting
The First Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang
Shengjin Fan
- Not yet recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650100
Sanbin Wang, Sanbin1011@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Fei Li
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Hongyu Zhang
- Not yet recruiting
Shanxi Tumor Hospital Affiliated to Shanxi Medical University
Taiyuan, Shanxi
Liping Su
- Not yet recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Erlie Jiang
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Yicheng Zhang
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Linghui Xia
- Not yet recruiting
Tangdu Hospital, PLA Air Force Military Medical University
Xi’an, Shanxi
Li Liu
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhongxing Jiang
About this study
Official title: Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
Read the detailed description
Thrombocytopenia is a common and severe complication after haplo-HSCT, including primary isolated thrombocytopenia (PIT) and secondary failure of platelet recovery (SFPR), which may cause bleeding and infection, and thus influence the OS, DFS, and NRM of the patients. Avatrombopag has been proved effective and safe in patients with chronic liver disease(CLD) and immune thrombocytopenia (ITP) and have been approved for CLD-associated thrombocytopenia undergoing elective invasive procedure (FDA\&NMPA) and ITP(FDA). Chinese consensus has recommended avatrombopag and some other thrombopoietin receptor agonists (TPO-RAs) to treat thrombocytopenia after haplo-HSCT. However, it lacks prospective studies to support that.Investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haplo-HSCT through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
The patients with PLT<20×10^9/L or transfusion dependent on the 7th day (+D7) after haplo-HSCT are included and assigned in a 1:1 randomization schedule to the avatrombopag group (receiving avatrombopag, n=71）and the placebo group (receiving placebo, n=71). The primary endpoint is the proportion of participants whose PLT≥50×10^9/L on +D60 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above. Second endpoints includ the proportion of participants whose PLT≥100×10^9/L on +D60 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the proportion of participants whose PLT≥20×10^9/L and whose PLT≥50×10^9/L on +D30 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the proportion of participants whose PLT≥50×10^9/L and whose PLT≥100×10^9/L on +D90 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the first day to achieve PLT≥20×10^9/L and PLT≥50×10^9/L and PLT≥100×10^9/L without the need for PLT transfusion for consecutive 7 days and above within +D60 after haplo-HSCT, the percentage of participants who need PLT transfusion and the average count of PLT from +D7 to + D60 after haplo-HSCT, the first day and the percentage of participants to achieve absolute neutrophil≥500/μL for consecutive 3 days within +D30 after haplo-HSCT, the graft-versus-host disease(GVHD), infection, the overall survival(OS),the disease free survival(DFS) and the non-relapse mortality(NRM) rates of participants within the first year after haplo-HSCT.
- Being tested
- avatrombopag, Placebo
- Keywords
- Thrombocytopenia, hematopoietic stem cell transplantation, haploidentical
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avatrombopagDrug
Also called Doptelet
The avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT<50×10^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days or PLT≥300×10^9/L and without PLT transfusion, stop avatrombopag; When PLT<50×10^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d.
PlaceboDrug
The placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT<50×10^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days or PLT≥300×10^9/L and without PLT transfusion, stop placebo; When PLT<50×10^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| avatrombopag | Experimental | Avatrombopag 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.
Adjustment indication:
When PLT<50×10^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10^9/L excluding the factor of PLT transfusion, stop administration; When PLT<50×10^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d.
PLT transfusion Indication: When PLT<20×10^9/L, and/or with the symptom or risk of bleeding. Receives: Drug: avatrombopag |
| Placebo | Placebo comparator | Placebo 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.
Adjustment indication:
When PLT<50×10^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10^9/L excluding the factor of PLT transfusion, stop administration; When PLT<50×10^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d.
PLT transfusion Indication: When PLT<20×10^9/L, and/or with the symptom or risk of bleeding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of complete response(CR) on day 60 after haplo-HSCT
the proportion of participants whose PLT≥50×10^9/L on day 60 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above
Measured: from randomization to day 60 after haplo-HSCT
Secondary outcomes (10)
the proportion of resonse(R)/remission on day 60 after haplo-HSCT
the proportion of participants whose PLT≥20×10^9/L or PLT≥100×10^9/L on day 60 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above
Measured: from randomization to day 60 after haplo-HSCT
the proportion of R/CR on day 30 after haplo-HSCT
the proportion of participants whose PLT≥20×10^9/L or PLT≥50×10^9/L on day 30 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above,respectively
Measured: from randomization to day 30 after haplo-HSCT
the proportion of CR/remission on day 90 after haplo-HSCT
the proportion of participants whose PLT≥50×10^9/L or PLT≥100×10^9/L on day 90 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above
Measured: from randomization to day 90 after haplo-HSCT
Time to R/CR/remission
the first day of the time to achieve PLT≥20×10^9/L and PLT≥50×10^9/L or PLT≥100×10^9/L independent of PLT transfusion for consecutive 7 days and above within 60 days after haplo-HSCT,respectively
Measured: from randomization to day 60 after haplo-HSCT
PLT transfusion dependence
the percentage of participants who need PLT transfusion and the average volume of transfused PLT from day 7 to day 60 after haplo-HSCT
Measured: from randomization to day 60 after haplo-HSCT
neutrophil engraftment
the first day and the percentage of participants to achieve absolute neutrophil≥500/μL for consecutive 3 days within 30 days after haplo-HSCT
Measured: from randomization to day 30 after haplo-HSCT
GVHD
the incidece of graft versus host disease(GVHD)
Measured: from randomization to 1 year after haplo-HSCT
overall survival(OS)
the 1-year OS of participants
Measured: from randomization to 1 year after haplo-HSCT
disease free survival(DFS)
the 1-year DFS of participants
Measured: from randomization to 1 year after haplo-HSCT
non-relapse mortality(NRM)
the 1-year NRM of participants
Measured: from randomization to 1 year after haplo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start13 May 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Shanxi Bethune Hospital, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Tang-Du Hospital, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202625
- Sponsor's protocol ID
- 2023PHD009-001
- Acronym
- Haplo-HSCT
- Status last verified
- Sep 2024
- First submitted
- 14 Dec 2023
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06202625
- Acronym / sponsor ID
- Haplo-HSCT / 2023PHD009-001
- Keywords
- Thrombocytopenia, hematopoietic stem cell transplantation, haploidentical
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Shanxi Bethune Hospital, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Tang-Du Hospital, The First Affiliated Hospital of Nanchang University
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Jan 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.
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
Detailed description
Thrombocytopenia is a common and severe complication after haplo-HSCT, including primary isolated thrombocytopenia (PIT) and secondary failure of platelet recovery (SFPR), which may cause bleeding and infection, and thus influence the OS, DFS, and NRM of the patients. Avatrombopag has been proved effective and safe in patients with chronic liver disease(CLD) and immune thrombocytopenia (ITP) and have been approved for CLD-associated thrombocytopenia undergoing elective invasive procedure (FDA\&NMPA) and ITP(FDA). Chinese consensus has recommended avatrombopag and some other thrombopoietin receptor agonists (TPO-RAs) to treat thrombocytopenia after haplo-HSCT. However, it lacks prospective studies to support that.Investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haplo-HSCT through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
The patients with PLT<20×10^9/L or transfusion dependent on the 7th day (+D7) after haplo-HSCT are included and assigned in a 1:1 randomization schedule to the avatrombopag group (receiving avatrombopag, n=71）and the placebo group (receiving placebo, n=71). The primary endpoint is the proportion of participants whose PLT≥50×10^9/L on +D60 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above. Second endpoints includ the proportion of participants whose PLT≥100×10^9/L on +D60 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the proportion of participants whose PLT≥20×10^9/L and whose PLT≥50×10^9/L on +D30 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the proportion of participants whose PLT≥50×10^9/L and whose PLT≥100×10^9/L on +D90 after haplo-HSCT without the need for PLT transfusion for 7 consecutive days or above, the first day to achieve PLT≥20×10^9/L and PLT≥50×10^9/L and PLT≥100×10^9/L without the need for PLT transfusion for consecutive 7 days and above within +D60 after haplo-HSCT, the percentage of participants who need PLT transfusion and the average count of PLT from +D7 to + D60 after haplo-HSCT, the first day and the percentage of participants to achieve absolute neutrophil≥500/μL for consecutive 3 days within +D30 after haplo-HSCT, the graft-versus-host disease(GVHD), infection, the overall survival(OS),the disease free survival(DFS) and the non-relapse mortality(NRM) rates of participants within the first year after haplo-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| avatrombopag | Experimental | Drug: avatrombopagAvatrombopag 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed. Adjustment indication: When PLT<50×10^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10^9/L excluding the factor of PLT transfusion, stop administration; When PLT<50×10^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d. PLT transfusion Indication: When PLT<20×10^9/L, and/or with the symptom or risk of bleeding. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed. Adjustment indication: When PLT<50×10^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10^9/L excluding the factor of PLT transfusion, stop administration; When PLT<50×10^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d. PLT transfusion Indication: When PLT<20×10^9/L, and/or with the symptom or risk of bleeding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged between 18-65 years;
- PLT<20×10^9/L or transfusion dependent on +D7 after haplo-HSCT;
- Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.
Key exclusion criteria (13 listed)
- With active infection;
- ALT or AST>3ULN, or total Bil>2ULN
- Ccr<50 mL/min;
- With the history of arteriovenous thrombosis;
- With history of cardiovascular disease (such as NYHA Class III/IV congestive heart failure, arrhythmia that increases the risk of thromboembolic events [such as atrial fibrillation] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting;
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 |
|---|---|---|
| avatrombopagAlso: DopteletThe avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT<50×10^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days or PLT≥300×10^9/L and without PLT transfusion, stop avatrombopag; When PLT<50×10^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d. | Drug | avatrombopag |
| PlaceboThe placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT<50×10^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10^9/L for 7 consecutive days or PLT≥300×10^9/L and without PLT transfusion, stop placebo; When PLT<50×10^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d. | Drug | Placebo |
Primary outcome
the proportion of complete response(CR) on day 60 after haplo-HSCT
Time frame: from randomization to day 60 after haplo-HSCT
the proportion of participants whose PLT≥50×10^9/L on day 60 after haplo-HSCT independent of PLT transfusion for 7 consecutive days or above
10 secondary outcomes
the proportion of resonse(R)/remission on day 60 after haplo-HSCT
Time frame: from randomization to day 60 after haplo-HSCT
the proportion of R/CR on day 30 after haplo-HSCT
Time frame: from randomization to day 30 after haplo-HSCT
the proportion of CR/remission on day 90 after haplo-HSCT
Time frame: from randomization to day 90 after haplo-HSCT
Time to R/CR/remission
Time frame: from randomization to day 60 after haplo-HSCT
PLT transfusion dependence
Time frame: from randomization to day 60 after haplo-HSCT
neutrophil engraftment
Time frame: from randomization to day 30 after haplo-HSCT
GVHD
Time frame: from randomization to 1 year after haplo-HSCT
overall survival(OS)
Time frame: from randomization to 1 year after haplo-HSCT
disease free survival(DFS)
Time frame: from randomization to 1 year after haplo-HSCT
non-relapse mortality(NRM)
Time frame: from randomization to 1 year after haplo-HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Thrombocytopenia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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.
Xiaohui Zhang principal investigator
Peking University People's Hospital
14 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 avatrombopag in people with Thrombocytopenia and Stem Cell Transplant Complications, run by Peking University People's Hospital at 14 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 3 inclusion and 13 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haixia Fu (13581830157, fuhaixia_210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of complete response(CR) on day 60 after haplo-HSCT (time frame: from randomization to day 60 after haplo-HSCT). 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 1 Oct 2024.