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Erythropoietin for Management of Anemia Caused by Chemotherapy

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Darbepoetin alfa

R-CHOP

About this trial

This is an interventional supportive care trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darbepoietin alfa

Arm Description

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.

Outcomes

Primary Outcome Measures

Hematopoietic response

Hemoglobin level after Darbepoietin alfa administration

Secondary Outcome Measures

Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia

Adverse events as measured by CTCAE v3.0

Proportion of patients requiring red blood cell transfusions

Mean time to response of hemoglobin

Full Information

NCT ID

NCT02890602

First Posted

August 18, 2016

Last Updated

February 19, 2020

Sponsor

Kosin University Gospel Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02890602

Brief Title

Erythropoietin for Management of Anemia Caused by Chemotherapy

Official Title

A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2012 (undefined)

Primary Completion Date

November 28, 2017 (Actual)

Study Completion Date

December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kosin University Gospel Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Darbepoietin alfa

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Other Intervention Name(s)

Nesp

Intervention Description

Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.

Intervention Type

Drug

Intervention Name(s)

R-CHOP

Other Intervention Name(s)

Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone

Intervention Description

R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.

Primary Outcome Measure Information:

Title

Hematopoietic response

Description

Hemoglobin level after Darbepoietin alfa administration

Time Frame

hemoglobin level of day 21 after Darbepoietin alfa administration

Secondary Outcome Measure Information:

Title

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

Title

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.

Title

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

Title

Mean time to response of hemoglobin

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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Erythropoietin for Management of Anemia Caused by Chemotherapy

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