Diffuse Large B-cell LymphomaPhase 2NCT02890602
Erythropoietin for Management of Anemia Caused by Chemotherapy
A Phase 2 study testing Darbepoetin alfa and R-CHOP in people with Diffuse Large B-cell Lymphoma, run by Kosin University Gospel Hospital.
Trial summary
This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate hematopoietic response of darbepoietin alfa and the quality of life assessment of increasement of hemoglobin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Darbepoetin alfa and R-CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 7 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diffuse large B cell lymphoma treated with R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy
- hemoglobin < 10.0 g/dL are shown at least 3 cycles after starting R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone)
- Currently receiving or planning to receive at least 4 times of darbepoetin
- Age > 18 years
- ECOG(Eastern Cooperative Oncology Group) performance status 0-2
- Bilirubin < 2 times upper limit of normal
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- ALT(alanine aminotransferase) or AST(aspartate aminotransferase) < 5 times upper limit of normal
- Creatinine < 2 times upper limit of normal
- HIV negative
- Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
- Can read Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia
- Agree with informed consent
Who cannot join
- Received radiation therapy at least 4 weeks before starting chemotherapy
- serious pre-existing medical condition (e.g., cardiac failure [New York Heart Association Class III or IV, or left ventricular ejection fraction <50%], active peptic ulceration, uncontrolled diabetes mellitus, or acute diffuse infiltrative pulmonary disease)
- uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
- arrhythmia NCI CTCAE grade ≥ 2
- History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months
- active systemic infection requiring treatment, a known diagnosis of human HIV, or active hepatitis B (hepatitis B carriers were permitted)Malignancy was treated surgically or with local radiation therapy with curative intent and the patient has been disease free for > 3 years
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- known hypersensitivity to darbepoetin alfa
- pregnant or nursing and Negative pregnancy test
- previous diagnosis of another malignancy with radiographic or biochemical evidence of residual disease (except completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or an in-situ malignancy)
- combined iron deficiency anemia
- received erythropoietin at least one months before starting darbepoetin
- considered autologous stem cell transplantation before finish 6 cycles of chemotherapy
- untreated primary or metastatic CNS(central nervous system) malignancy
About this study
Official title: A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate hematopoietic response of darbepoietin alfa and the quality of life assessment of increasement of hemoglobin.
Read the detailed description
Darbepoietin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with malignant lymphoma. Darbepoietin will be applied to R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy every 21days ± 2days with fixed 360㎍. It will be applied to chemotherapy until increment of hemoglobin 12.0g/dL. If the hemoglobin level exceeds 12.0g/dL, administration of darbepoietin will be temporarily stopped.
And, the questionnaire of the quality of life will be conducted at the baseline, after 2th darbepoietin alfa administration, at study completion.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Darbepoetin alfa, R-CHOP
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Nesp
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
R-CHOPDrug
Also called Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone
R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
| Study group | Role | What they receive |
|---|---|---|
| Darbepoietin alfa | Experimental | Hemoglobin level will be checked at every cycle's day 0 or 1(1cycle is 21days) after starting Darbepoietin alfa. It will be applied to chemotherapy until increment of hemoglobin 12.0 g/dL. Receives: Drug: Darbepoetin alfa; Drug: R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematopoietic response
Hemoglobin level after Darbepoietin alfa administration
Measured: hemoglobin level of day 21 after Darbepoietin alfa administration
Secondary outcomes (4)
Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia
Measured: at baseline, Day 21 after 2th darbepoietin alfa administration, Day 21 after last darbepoietin alfa administration
Adverse events as measured by CTCAE v3.0
Measured: From the date of first drug administration to the date of the 30th days of last drug administration.
Proportion of patients requiring red blood cell transfusions
Measured: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
Mean time to response of hemoglobin
Measured: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start1 Sep 2012
- Primary completion28 Nov 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sup Lee, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890602
- Sponsor's protocol ID
- EPOMA
- Status last verified
- Feb 2020
- First submitted
- 18 Aug 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02890602
- Acronym / sponsor ID
- EPOMA
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Study start
- 1 Sep 2012
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 7 Sep 2016 (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 a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate hematopoietic response of darbepoietin alfa and the quality of life assessment of increasement of hemoglobin.
Detailed description
Darbepoietin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with malignant lymphoma. Darbepoietin will be applied to R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy every 21days ± 2days with fixed 360㎍. It will be applied to chemotherapy until increment of hemoglobin 12.0g/dL. If the hemoglobin level exceeds 12.0g/dL, administration of darbepoietin will be temporarily stopped.
And, the questionnaire of the quality of life will be conducted at the baseline, after 2th darbepoietin alfa administration, at study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darbepoietin alfa | Experimental | Drug: Darbepoetin alfa, Drug: R-CHOPHemoglobin level will be checked at every cycle's day 0 or 1(1cycle is 21days) after starting Darbepoietin alfa. It will be applied to chemotherapy until increment of hemoglobin 12.0 g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed diffuse large B cell lymphoma treated with R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy
- hemoglobin < 10.0 g/dL are shown at least 3 cycles after starting R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone)
- Currently receiving or planning to receive at least 4 times of darbepoetin
- Age > 18 years
- ECOG(Eastern Cooperative Oncology Group) performance status 0-2
Key exclusion criteria (13 listed)
- Received radiation therapy at least 4 weeks before starting chemotherapy
- serious pre-existing medical condition (e.g., cardiac failure [New York Heart Association Class III or IV, or left ventricular ejection fraction <50%], active peptic ulceration, uncontrolled diabetes mellitus, or acute diffuse infiltrative pulmonary disease)
- uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
- arrhythmia NCI CTCAE grade ≥ 2
- History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months
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 |
|---|---|---|
| Darbepoetin alfaAlso: NespDarbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay. | Drug | Darbepoietin alfa |
| R-CHOPAlso: Rituximab, Cyclophosphamide, Adriamycin, Vincristine, PrednisoloneR-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients. | Drug | Darbepoietin alfa |
Primary outcome
Hematopoietic response
Time frame: hemoglobin level of day 21 after Darbepoietin alfa administration
Hemoglobin level after Darbepoietin alfa administration
4 secondary outcomes
Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia
Time frame: at baseline, Day 21 after 2th darbepoietin alfa administration, Day 21 after last darbepoietin alfa administration
Adverse events as measured by CTCAE v3.0
Time frame: From the date of first drug administration to the date of the 30th days of last drug administration.
Proportion of patients requiring red blood cell transfusions
Time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
Mean time to response of hemoglobin
Time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin alfa and R-CHOP in people with Diffuse Large B-cell Lymphoma, run by Kosin University Gospel Hospital.
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 12 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematopoietic response (time frame: hemoglobin level of day 21 after Darbepoietin alfa administration). 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 20 Feb 2020.