Erythropoietin for Management of Anemia Caused by Chemotherapy

NCT02890602 | Completed Phase 2

• 1 other identifier: EPOMA
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Hematopoietic response

  Hemoglobin level after Darbepoietin alfa administration

  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

  at baseline, Day 21 after 2th darbepoietin alfa administration, Day 21 after last darbepoietin alfa administration

• 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.

• Proportion of patients requiring red blood cell transfusions

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

• Mean time to response of hemoglobin

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

Study Arms (1)

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.

Drug: Darbepoetin alfa; Drug: R-CHOP

Interventions

Darbepoetin alfa DRUG

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

Darbepoietin alfa

R-CHOP DRUG

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

Darbepoietin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Darbepoetin alfa; R-CHOP protocol; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. associate professor, Division of hematology-Oncology

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2012
• Primary Completion: November 28, 2017
• Study Completion: December 7, 2017
• Last Updated: February 20, 2020

Record last verified: 2020-02