Evaluation of post-salvage therapy hospitalization period in patients with malignant lymphoma

JRCT ID: jRCTs071180008

Registered date:27/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Relapsed or refractory malignant lymphoma
• Date of first enrollment: 20/07/2017
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Patients receive a single subcutaneous injection of pegfilgrastim (3.6 mg) 2 days after chemotherapy.

Outcome(s)

• Primary Outcome: Ratio of outpatient management period (days)

Secondary Outcome

1) Readmission rate due to febrile neutropenia
2) All-cause readmission rate
3) Number of transfusions (RBC, Platelet)
4) Number of outpatient visits
5) Relative dose intensity
6) Cost analysis
7) Utilization rate of antibiotics
8) Patient satisfaction
9) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Relapsed or refractory non-hodgkins lymphoma and hodgkins lymphoma
2)Age >= 20 years old at informed consent
3)ECOG PS <= 2
4)Patients who are going to receive (R)EPOCH, CHASE(R), (R)DeVIC or (R)ESHAP regimen.
5)Patients who meet the following criteria within 14 days
before salvage therapy.
Neutrophil count >= 1,000/ul
Platelet >= 50,000/ul
Total bilirubin level <= 2 times the upper normal limit in institute
Serum creatinine <= 1.5mg/dl
6) Patients who can immediately go to hospital when the
condition changed suddenly.
7) Given written informed consent

Exclude criteria

1)Patients who have a possibility of severe infection after the entry or active infection at the entry.
2)Pregnant or breast-feeding females and females who have a possibility of pregnancy.
3)Patients who have any other inadequacy for this study by physicians.

Related Information

• Primary Sponsor: Iwasaki Hiromi
• Source(s) of Monetary Support: Kyowa Hakko Kirin
• Secondary ID(s): UMIN000028082