UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012664 |
|---|---|
| Receipt number | R000014351 |
| Scientific Title | Dose-intensified pirarubicin-cyclophosphamide, vincristine and prednisolone regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial. |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2021/04/15 13:04:30 |
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Basic information
Public title
Dose-intensified pirarubicin-cyclophosphamide, vincristine and prednisolone regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.
Acronym
Dose-intensified THP-COP regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.
Scientific Title
Dose-intensified pirarubicin-cyclophosphamide, vincristine and prednisolone regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.
Scientific Title:Acronym
Dose-intensified THP-COP regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.
Region
| Japan |
Condition
Condition
Newly diagnosed adult peripheral T cell lymphoma patients, including those with peripheral T-cell lymphoma, not otherwise specified,
angioimmunoblastic T-cell lymphoma,
anaplastic large cell lymphoma (ALK negative),
enteropathy-associated T-cell lymphoma,
hepatosplenic T-cell lymphoma.
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present phase II study is conducted in patients with adult PTCL to test the feasibility of the Double-THP-COP regimen followed by consolidative high-dose chemotherapy by evaluating response rate, survival and toxicity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Three years event free survival(EFS)
Key secondary outcomes
Overall response rate (ORR)
Complete remission (CR) rate
Three or five years disease free survival (DFS)
Five years event free survival (EFS)
Three or five years overall survival (OS)
Incidence and grade of toxicity
Influence on outcome by lymphoma prognostic factor (IPI,PIT)
Prognostic comparison between AutoPBSCT cases and HD-MTX cases
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The Double-THP-COP regimen consists of 3 courses of intravenous (i.v.) administration of cyclophosphamide (750 mg/m2, days 1-2, 3h), pirarubicine (40 mg/m2, days 1-2, 30 min), vincristine (1.4 mg/m2, day 1, max 2 mg/body), and per os (p.o.) prednisone (50 mg/m2, days 1-5). For patients aged over 60, cyclophosphamide dose is modified as follows: course 1, 750 mg/m2, day 1; course 2, 500 mg/m2, days 1-2; and course 3, 750 mg/m2, days 1-2. Treatment intensity is augmented during every course unless leukocyte recovery (WBC count, more than 3,000/ul on day 23) is delayed or an adverse event (more than grade 3) other than haematological toxicities developed. When patients developed more than grade 3 neutropenia, granulocyte colony-stimulating factor (G-CSF) is administered until neutrophil counts recovered. To administer subsequent courses of Double-THP-COP, an absolute leukocyte count more than 3,000/ul, neutrophil count more than 1,000/ul, and platelet count more than 100,000/ul are required. If patients are i) 65 years or younger, ii) have an acceptable ECOG PS, and iii) achieve complete remission (CR) or unconfirmed CR (CRu) within 3 courses of Double-THP-COP, their peripheral blood stem cells are collected and subsequent HDT/ASCT is performed. The third cycle of Double-THP-COP regimen is used for stem cell mobilization. Consolidating high-dose chemotherapy regimen (HDC) consists of cyclophosphamide (60 mg/kg, day -7 and -6, i.v. 3 h), etoposide (500 mg/m2; day -6, -5, and -4; i.v. 6-8 h), and ranimustine (250 mg/m2, day -3 and -2, i.v. 1 h). Autologous stem cell transplantation (ASCT) is performed on day 0 and G-CSF is administered from day 1 until neutrophil engraftment. As an alternative to HDT/ASCT, HDMTX (100 mg/kg, day 1, i.v. 4h) is performed for patients who can not yield a sufficient number of stem cells or are ineligible for HDC.
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with PTCLs (by pathological finding) with stage II or more are subject to the study.
Also, patients are required to be treated in our hospital.
PTCLs includes the subtypes as shown below:
Peripheral T-cell lymphoma, not otherwise specified
Angioimmunoblastic T-cell lymphoma
Anaplastic large cell lymphoma, ALK negative
Enteropathy-associated T-cell lymphoma
Hepatosplenic T-cell lymphoma
Key exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 4
serum total Bilirubin > 1.5mg/dl
serum creatinine >2.0mg/dl
Ejection-Fraction<50% by electrocardiogram
If these complications described above are considered to be attributed to underlying disease, those patients are included when the complications are recovered with the standard treatment.
Invasion to the central nervous system from the first diagnosis
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of Hematology and Rheumatology
Zip code
183-8610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan.
TEL
03-3972-8111
hitakahashi-nhn@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of Hematology and Rheumatology
Zip code
183-8610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan.
TEL
03-3972-8111
Homepage URL
hitakahashi-nhn@umin.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non
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
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchikami-cho Itabashi-ku, Tokyo, Japan.
Tel
0339728111
hiromichi2070@gmail.com
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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014351
