Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    134
  • sponsor
    Samsung Medical Center
Updated on 26 January 2021
cyclophosphamide
vincristine
prednisone
etoposide
dexamethasone
doxorubicin
enteropathy
panniculitis
t-cell lymphoma
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma
intestinal t-cell lymphoma

Summary

This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.

Description

It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently used but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to consider the clinical trial at NCCN guideline.But why the CHOP regimen is widely used because physicians are accustomed to use. Fractionated ICED therapy is a therapy by adjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into three days. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvage therapy of patients with relapsed or refractory lymphoma for a long time, it has been recommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added to dexamethasone therapy in order to improve the effectiveness as a primary therapy.The recurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stem cell transplantation, showed a more than 40% progression-free survival.Thus treatment of Fractionated ICED targeting previously untreated patients, and if a combination of high-dose dexamethasone to expect to be able to induce a progression-free survival of 60% or more.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma
Treatment CHOP, fractionated ICED
Clinical Study IdentifierNCT02445404
SponsorSamsung Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 19-65 years
Informed consent
Subject able to adhere to the study visit schedule and other protocol requirements
Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes
PTCL, not otherwise specified
Angioimmunoblastic T-cell lymphoma
Anaplastic large cell lymphoma, ALK-negative type
Enteropathy-associated T-cell lymphoma
Hepato-splenic T-cell lymphoma
Subcutaneous panniculitis-like T-cell lymphoma
Primary cutaneous gamma-delta T-cell lymphoma
Primary cutaneous CD8+ aggressive epidermotropic lymphoma
Other non classifiable T-cell Lymphoma
Performance status (ECOG) 0,1 or 2
A negative pregnancy test prior to treatment must be available both for pre-menopausal women
Female of childbearing potential (FCBP) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP.Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following IP discontinuation
life expectancy90day(3months)

Exclusion Criteria

Other serious medical illnesses or psychiatric disorders
Any state that the confusion in the interpretation of test result
Other type lymphoma ex) B-cell lymphoma
Other type T-cell lymphoma
Adult T-Cell Leukemia/Lymphoma
NK/T-cell Lymphoma, Nasal Type
ALK-Positive Anaplastic Large-Cell Lymphoma
Cutaneous Tcell lymphoma
primary cutaneous CD30+ lympho- proliferative disorder
primary cutaneous Anaplastic T cell lymphoma
Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)
Previous radiation therapy
CNS involvement
If the contraindication to chemoherapy
Subject has known historical or active infection with HIV
BM function: ANC < 1.5 109/L; Platelet count <100,000/mm2 (100 109/L), SGOT/AST or SGPT/ALT 3.0 x ULN, Bilirubin> 2 x upper normal value
serum creatinine level > 2.0 x ULN
Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
MUGA scan <45%
Those who administered doxorubicin exceeding 200 mg / m2
Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Breast-feeding or pregnant female
Clear my responses

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