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

Phase 4

• Conditions: Relapsed or refractory malignant lymphoma

• Registration Number: JPRN-jRCTs071180008
• Lead Sponsor: Iwasaki Hiromi

Brief Summary

The study data indicated that treatment with pegfilgrastim allowed management of patients receiving salvage therapy as outpatients. Given that there was no case of hospitalization due to FN during outpatient management and that no clinically significant safety concern was noted, outpatient management after salvage therapy seems acceptable.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-27
• Study Completion: 2019-12-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified