UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter, phase II study of full-dose THP-COP therapy for elderly patients with newly diagnosed, advanced-stage, aggressive non-Hodgkin lymphoma
Acronym	THP-1
Scientific Title	A multicenter, phase II study of full-dose THP-COP therapy for elderly patients with newly diagnosed, advanced-stage, aggressive non-Hodgkin lymphoma
Scientific Title:Acronym	THP-1
Region	Japan

Condition
Condition	aggressive lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the THP efficacy and safety in elderly patients with newly diagnosed, advanced-stage, aggressive NHL
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	complete response rate
Key secondary outcomes	Failure free survival, progression free survival, safty

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For THP-COP therapy, 50mg/m2 THP, 750 mg/m2 CPA, and 1.4mg/m2 VCR (max 2.0 mg/body) were administered on day 1, and 100mg/body PDN was administered on days 1~5 in accordance with the CHOP regimen regulations. This regimen was administered every 3 weeks for up to six courses. If the THP dose was decreased due to toxicity, up to two courses of additional treatment were administered to permit the cumulative dose of THP to reach 300 mg/m2.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	70 to 79 years of age, previously untreated, Working Formulation D through H and J , clinical stage I disease with a bulky mass or stage II,III,IV disease according to the Ann Arbor classification , Eastern Cooperative Oncology Group performance status of 0,1
Key exclusion criteria	any other malignancies, mental illness, myocardial infarction or angina history, central nervous system infiltration, uncontrollable diabetes, human immunodeficiency virus infection, hepatitis B virus surface antigen, and/or hepatitis C virus antibody positivity were excluded.
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Tomomitsu Middle name Last name Hotta
Organization	Nagoya medical center
Division name	Division of hematology
Zip code	460-0001
Address	Nagoya
TEL	052-951-1111
Email	hottat@nnh.hosp.go.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Ohmachi
Organization	Tokai university, school of medicine
Division name	hematology
Zip code	259-1193
Address	Kanagawa
TEL	0463-93-1121
Homepage URL
Email	8jmmd004@is.icc.u-tokai.ac.jp

Sponsor
Institute	the Hematological Malignancy Clinical Study Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokai university, school of medicine
Address	Kanagawa
Tel	0463-93-1121
Email	8jmmd004@is.icc.u-tokai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 22 Day

Related information
URL releasing protocol	http://www.hmcsg.umin.jp/
Publication of results	Partially published

Result
URL related to results and publications	http://www.hmcsg.umin.jp/
Number of participants that the trial has enrolled	30
Results	The CR rate was 65.5% (95% confidence interval, 45.7~82.1%). The 3-year failure-free and overall survival rates were 54.1% and 53.9%, respectively.
Results date posted	2022 Year 08 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The age of the registered patients ranged from 70 to 79 years old, with a median of 72 years old. Out of the 30 patients in total, 20 (65.5%) patients were 70~74 years of age, and 10 (34.5%) were 75~79 years of age. Fourteen patients (46.7%) were PS 0, and 16 patients (53.3%) were PS 1. Regarding histopathological type, 19 patients (63.3%) had diffuse large B-cell lymphoma (DLBCL). Regarding the clinical stage, 16 (53.3%) patients had stage II disease, 14 (46.7%) had stage III~IV disease, and three patients (10.0%) had a bulky mass. When the 29 eligible patients were stratified into four groups on the IPI basis, 8 patients (26.7%) were in the low-risk group, 10 patients (33.3%) were in the low-intermediate-risk group, 12 patients (40.0%) were in the high-intermediate-risk group, and no patient was in the high-risk group.
Participant flow	A total of 30 patients (19 males and 11 females) from 6 hospitals belonging to the Hematological Malignancy Clinical Study Group (HMCSG) were registered between January 1999 and June 2000.
Adverse events	The most frequent observed grade 3 or 4 toxicity was neutropenia, which occurred in 80% of the patients. Grade 3 cardiac dysfunction was observed in one patient.
Outcome measures	primary endpoint was met
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	1999 Year 01 Month 01 Day
Date of IRB	1998 Year 12 Month 01 Day
Anticipated trial start date	1999 Year 01 Month 01 Day
Last follow-up date	2005 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 22 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055514