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

Samsung Medical Center134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Peripheral T-cell Lymphoma

Interventions

CHOPDRUG

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 ICEDDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 19-65 years 2. Informed consent 3. Subject able to adhere to the study visit schedule and other protocol requirements. 4. 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 5. Performance status (ECOG) 0,1 or 2 6. A negative pregnancy test prior to treatment must be available both for pre-menopausal women 7. 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. 8. life expectancy≥90day(3months) Exclusion Criteria: 1. Other serious medical illnesses or psychiatric disorders 2. Any state that the confusion in the interpretation of test result. 3. Other type lymphoma ex) B-cell lymphoma 4. 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 5. Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days) 6. Previous radiation therapy 7. CNS involvement. 8. If the contraindication to chemoherapy 9. Subject has known historical or active infection with HIV. 10. 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 11. serum creatinine level \> 2.0 x ULN 12. Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 13. MUGA scan \<45% 14. Those who administered doxorubicin exceeding 200 mg / m2 15. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 16. Breast-feeding or pregnant female

Locations (1)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

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

Time frame: 3 years

overall response rate

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

Time frame: 3 years

Response duration

Time frame: 3 years

Toxicity profiles

Toxicity profiles as measured by Adverse Events and Laboratory results.

Time frame: 3 years

Central Contacts

Won Seog Kim, MD,Ph.D.

CONTACT

234106548 wskimsmc@skku.edu

Data from ClinicalTrials.gov

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