Allogeneic Hematopoietic Stem Cell TransplantationNCT03902041
The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation and Eltrombopag, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Eltrombopag
- What is being tested?
- Eltrombopag
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Oct 2022
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients after allogeneic hematopoietic stem cell transplantation
Who may be able to join
- Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
- Acceptance of allogeneic hematopoietic stem cell transplantation;
- Voluntary acceptance of the study
Who cannot join
- Patients with severe organ dysfunction or disease；
- Patients who cannot tolerate oral Eltrombopag therapy;
- Patients who refuse all-HSCT and Eltrombopag treatment;
- Patients that investigator believed not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
Xin Wang contact
China1 site
Heamtology Department, Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, 250021
Xiaosheng Fang, 15168889703, fxsh_1010@126.com
Xin Wang, xinw007@126.com
About this study
Official title: The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.
Read the detailed description
With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.
- Being tested
- Eltrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
The patients will receive Eltrombopag treatment after transplantation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | The patients will receive Eltrombopag treatment after transplantation at d1. Receives: Drug: Eltrombopag | |
| Control Group | The patients will not receive Eltrombopag treatment after transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The engraftment of platelet
the day of platelet engraftment
Measured: 3 years
The levels of platelet
The levels of platelet at 30 days after transplantation
Measured: 3 years
Secondary outcomes (1)
The number of platelet transfusions
The number of platelet units be transfused to the patients before platelet engraftment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- Xin Wang, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902041
- Sponsor's protocol ID
- SDPH001
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2019
- Last updated
- 3 Apr 2019
- 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 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03902041
- Acronym / sponsor ID
- SDPH001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 3 Apr 2019 (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.
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.
Detailed description
With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Drug: EltrombopagThe patients will receive Eltrombopag treatment after transplantation at d1. |
| Control Group | – | –The patients will not receive Eltrombopag treatment after transplantation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients after allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (3 listed)
- Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
- Acceptance of allogeneic hematopoietic stem cell transplantation;
- Voluntary acceptance of the study
Key exclusion criteria (4 listed)
- Patients with severe organ dysfunction or disease；
- Patients who cannot tolerate oral Eltrombopag therapy;
- Patients who refuse all-HSCT and Eltrombopag treatment;
- Patients that investigator believed not suitable for enrollment.
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 |
|---|---|---|
| EltrombopagThe patients will receive Eltrombopag treatment after transplantation | Drug | Treatment Group |
Primary outcome
The engraftment of platelet
Time frame: 3 years
the day of platelet engraftment
The levels of platelet
Time frame: 3 years
The levels of platelet at 30 days after transplantation
1 secondary outcome
The number of platelet transfusions
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
Related trials for Allogeneic Hematopoietic Stem Cell Transplantation
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
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.
Xin Wang contact
Xin Wang principal investigator
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation and Eltrombopag, run by Shandong Provincial Hospital at 1 site 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 4 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xiaosheng Fang (15168889703, fxsh_1010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The engraftment of platelet (time frame: 3 years). The study lists 2 primary outcomes in all. 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 3 Apr 2019.