Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465527
• Other study ID #: Prephase
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2017
• Est. completion date: July 13, 2021

Study information

• Verified date: March 2022
• Source: Kosin University Gospel Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL

Description:

R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Histologically the first large-scaled B-cell lymphoma patient

2. Diagnosis time 65 years old or older

3. Patients planning R-CHOP chemotherapy

4. Ann Arbor stage 2 (bulky = diameter of 7cm), stage 3 or stage 4

5. The International Prognostic Index (IPI) is a high intermediate or high risk

6. Patients without prior history of lymphoma

7. The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria:

1. Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma

2. Large B-cell lymphoma involving the central nervous system

3. Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials

4. If the drug used in this study is allergic

5. If you do not agree to participate in the study

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• PrednisoLONE 50 MG
Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan	Sue-gu

Sponsors (1)

Lead Sponsor	Collaborator
Kosin University Gospel Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(treatment-related mortality rate; TRM)	treatment-related mortality rate	an average of 1 year
Secondary	IMWG fragility score before and after pre-phase treatment	International Myeloma Working Group,( IMWG)	an average of 1 year
Secondary	TRM and RR according to IMWG fragility score	International Myeloma Working Group,( IMWG)	an average of 1 year
Secondary	response rate; RR	response rate	an average of 1 year
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	safety	an average of 1 year
Secondary	Incidence of neutropenic fever	Incidence of neutropenic fever	an average of 1 year