AnemiaPhase 4NCT03010579
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation
A Phase 4 study testing erythropoietin and iron supplementation in people with Anemia and Lymphoma, run by Peking University at 1 site in China.
Trial summary
This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation
- What is being tested?
- erythropoietin and iron supplementation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 4
- 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
- confirmed lymphoma
- first autologous hematopoietic stem cell transplantation
- hemoglobin level less than 100 g/L on day +15 post-transplant
- written informed consent given by patient or his/her guardian if of minor age.
Who cannot join
- HIV positive
- Known allergy to recombinant human erythropoietin
- Uncontrolled infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Wei Ping Liu, dreaming2217@126.com
Xiao Pei Wang, cadillac570@163.com
About this study
Official title: Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.
Read the detailed description
Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.
- Conditions
- Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation
- Being tested
- erythropoietin, iron supplementation
- Keywords
- Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin
- Medical subject headings
- Anemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called Erythropoiesis-Stimulating Agent
Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
iron supplementationDrug
Also called ferrous succinate
If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin group | Experimental | For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered. Receives: Drug: erythropoietin |
| iron supplementation | Active comparator | If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered. Receives: Drug: iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete hemoglobin response rate
proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
Measured: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Secondary outcomes (2)
proportion of participants with red blood cell transfusions
proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant
Measured: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
proportion of participants with deep vein thrombosis
proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant
Measured: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Peking 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010579
- Sponsor's protocol ID
- PKU-2016KT64
- Status last verified
- Jan 2017
- First submitted
- 29 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03010579
- Acronym / sponsor ID
- PKU-2016KT64
- Conditions
- Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation
- Keywords
- Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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 is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.
Detailed description
Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythropoietin group | Experimental | Drug: erythropoietinFor those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered. |
| iron supplementation | Active comparator | Drug: iron supplementationIf necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed lymphoma
- first autologous hematopoietic stem cell transplantation
- hemoglobin level less than 100 g/L on day +15 post-transplant
- written informed consent given by patient or his/her guardian if of minor age.
Key exclusion criteria (3 listed)
- HIV positive
- Known allergy to recombinant human erythropoietin
- Uncontrolled infection
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 |
|---|---|---|
| erythropoietinAlso: Erythropoiesis-Stimulating AgentErythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered. | Drug | erythropoietin group |
| iron supplementationAlso: ferrous succinateIf necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered. | Drug | iron supplementation |
Primary outcome
complete hemoglobin response rate
Time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
2 secondary outcomes
proportion of participants with red blood cell transfusions
Time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
proportion of participants with deep vein thrombosis
Time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing erythropoietin and iron supplementation in people with Anemia and Lymphoma, run by Peking University 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 4 inclusion and 3 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 5 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete hemoglobin response rate (time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation). 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 5 Jan 2017.