Erythropoietin for Management of Anemia Caused by Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: Darbepoetin alfa; Drug: R-CHOP

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematopoietic response	Hemoglobin level after Darbepoietin alfa administration	hemoglobin level of day 21 after Darbepoietin alfa administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kosin University Gospel Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Hematinics; Prednisolone; Cyclophosphamide; Darbepoetin alfa; Vincristine
• Other Study ID Numbers: EPOMA