Peripheral T-cell Lymphoma Clinical Trial
Official title:
Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma
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.
Status | Recruiting |
Enrollment | 134 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul | Seoul, Korea, Republic Of |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | 3 years | |
Secondary | Response duration | 3 years | ||
Secondary | Toxicity profiles | Toxicity profiles as measured by Adverse Events and Laboratory results. | 3 years |
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