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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHOP | Active Comparator | cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks |
|
| Fractionated ICED | Experimental | ifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOP | Drug | cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | Time to disease progression is defined as the time from treatment start to the first recording of relapse or disease progression or death of any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Duration of survival is defined as the time from treatment start to death of any cause or the date of last follow-up. Subjects who are alive will be censored using the date at which they are last known to be alive | 3 years |
| overall response rate |
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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.
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 expectancy≥90day(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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Seog Kim, MD,Ph.D. | Contact | 234106548 | 82 | wskimsmc@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim, MD,Ph.D. | Samsung Medical Center,Seoul,Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Seoul, Korea, Republic of | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D007069 | Ifosfamide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| fractionated ICED | Drug | ifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks |
|
|
They should be classified as complete remission(CR),Partial remission(PR),Stable disease(SD), or progression disease(PD)according to the Revised Response Criteria for Malignant Lymphoma |
| 3 years |
| Response duration | 3 years |
| Toxicity profiles | Toxicity profiles as measured by Adverse Events and Laboratory results. | 3 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |