Erythropoietin for Management of Anemia Caused by Chemotherapy

Sponsor
Kosin University Gospel Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02890602
Collaborator
(none)
53
Enrollment
1
Arm
63.2
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Nov 28, 2017
Actual Study Completion Date :
Dec 7, 2017

Arms and Interventions

ArmIntervention/Treatment
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
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
Other Names:
  • Nesp
  • Drug: R-CHOP
    R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
    Other Names:
  • Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone
  • Outcome Measures

    Primary Outcome Measures

    1. Hematopoietic response [hemoglobin level of day 21 after Darbepoietin alfa administration]

      Hemoglobin level after Darbepoietin alfa administration

    Secondary Outcome Measures

    1. Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia [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 [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 [From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration]

    4. Mean time to response of hemoglobin [From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kosin University Gospel Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ho Sup Lee, MD, PhD. associate professor, Division of hematology-Oncology, Kosin University Gospel Hospital
    ClinicalTrials.gov Identifier:
    NCT02890602
    Other Study ID Numbers:
    • EPOMA
    First Posted:
    Sep 7, 2016
    Last Update Posted:
    Feb 20, 2020
    Last Verified:
    Feb 1, 2020

    Study Results

    No Results Posted as of Feb 20, 2020