UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048724 |
|---|---|
| Receipt number | R000055514 |
| 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 |
| Date of disclosure of the study information | 2022/08/22 |
| Last modified on | 2022/08/22 19:25:24 |
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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
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
8jmmd004@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
the Hematological Malignancy Clinical Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055514
