Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatments darbepoetin alfa, r-chop
Phase phase 2
Sponsor Kosin University Gospel Hospital
Start date September 2012
End date December 2016
Trial size 53 participants
Trial identifier NCT02890602, EPOMA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Hemoglobin level will be checked at every R-CHOP cycle's day 0 or 1 after starting Darbepoietin alfa. It will be applied to chemotherapy until increment of hemoglobin 12.0 g/dL.
darbepoetin alfa Nesp
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
r-chop Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone
R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.

Primary Outcomes

Measure
Hematopoietic response
time frame: hemoglobin level of day 21 after Darbepoietin alfa administration

Secondary Outcomes

Measure
Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia
time frame: at baseline, Day 21 after R-CHOP 2th cycle administration, Day 21 after last darbepoietin alfa administration
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.
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
Mean time to response of hemoglobin
time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
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 2 cycles of chemotherapy, at study completion.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kosin University Gospel Hospital.