Erythropoietin for Management of Anemia Caused by Chemotherapy

Sponsor

Kosin University Gospel Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02890602

Collaborator

(none)

Enrollment

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 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.

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

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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