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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Carboplatin; Cyclophosphamide; Dexamethasone; Etoposide; Ifosfamide; Prednisone; Vincristine

Criteria

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