UMIN-CTR Clinical Trial

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
Email	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
Email	hitakahashi-nhn@umin.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014351