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CompletedNCT02890602Updated Feb 20, 2020

Erythropoietin for Management of Anemia Caused by Chemotherapy

A Phase 2 interventional study of Darbepoetin alfa and R-CHOP in Diffuse Large B-cell Lymphoma, sponsored by Kosin University Gospel Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Kosin University Gospel Hospital · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 53 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Kosin University Gospel Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed diffuse large B cell lymphoma treated with R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy
  2. hemoglobin \< 10.0 g/dL are shown at least 3 cycles after starting R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone)
  3. Currently receiving or planning to receive at least 4 times of darbepoetin
  4. Age > 18 years
  5. ECOG(Eastern Cooperative Oncology Group) performance status 0-2
  6. Bilirubin \< 2 times upper limit of normal
  7. ALT(alanine aminotransferase) or AST(aspartate aminotransferase) \< 5 times upper limit of normal
  8. Creatinine \< 2 times upper limit of normal
  9. HIV negative
  10. Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
  11. Can read Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia
  12. Agree with informed consent

Exclusion criteria

Exclusion Criteria:

  1. Received radiation therapy at least 4 weeks before starting chemotherapy
  2. 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)
  3. uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
  4. arrhythmia NCI CTCAE grade ≥ 2
  5. History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months
  6. 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
  7. known hypersensitivity to darbepoetin alfa
  8. pregnant or nursing and Negative pregnancy test
  9. 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)
  10. combined iron deficiency anemia
  11. received erythropoietin at least one months before starting darbepoetin
  12. considered autologous stem cell transplantation before finish 6 cycles of chemotherapy
  13. untreated primary or metastatic CNS(central nervous system) malignancy
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Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Darbepoietin alfa

    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.

    Drug: Darbepoetin alfa · Drug: R-CHOP

Interventions

  • DrugDarbepoetin alfa

    Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.

    Also known as: Nesp

  • DrugR-CHOP

    R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.

    Also known as: Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone

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What researchers measure

Primary outcomes

  1. Hematopoietic response

    Hemoglobin level after Darbepoietin alfa administration

    Time frame: hemoglobin level of day 21 after Darbepoietin alfa administration

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. Mean time to response of hemoglobin

    Time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02890602
Lead sponsor
Kosin University Gospel Hospital
Responsible party
Ho Sup Lee (MD, PhD. associate professor, Division of hematology-Oncology, Kosin University Gospel Hospital) — Principal investigator
First posted
Sep 7, 2016
Start date
Sep 1, 2012
Primary completion
Nov 28, 2017
Completion
Dec 7, 2017
Last update
Feb 20, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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