Peripheral T-cell Lymphoma
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGCHOP
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
DRUGfractionated ICED
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
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | 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 |
| overall response rate | 3 years | 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 |
| Response duration | 3 years | — |
| Toxicity profiles | 3 years | Toxicity profiles as measured by Adverse Events and Laboratory results. |
Countries
South Korea
Contacts
Primary ContactWon Seog Kim, MD,Ph.D.
Outcome results
None listed