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Erythropoietin for Management of Anemia Caused by Chemotherapy

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ClinicalTrials.gov Identifier: NCT02890602
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ho Sup Lee, Kosin University Gospel Hospital

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 disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Darbepoetin alfa Drug: R-CHOP 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2012
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : December 7, 2017


Arm Intervention/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 Name: 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 Name: Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone




Primary Outcome Measures :
  1. Hematopoietic response [ Time Frame: 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 [ 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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: September 7, 2016    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisolone
Cyclophosphamide
Vincristine
Darbepoetin alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Inflammatory Agents
Glucocorticoids
Hormones