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

NCT ID: NCT02445404

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-23
• Study Completion Date: 2023-06-30

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.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHOP

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

Group Type: ACTIVE_COMPARATOR

CHOP

Intervention Type: 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

fractionated ICED

Intervention Type: 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

Fractionated 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

Group Type: EXPERIMENTAL

CHOP

Intervention Type: 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

fractionated ICED

Intervention Type: 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

Interventions

CHOP

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

Intervention Type: DRUG

fractionated 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

Intervention Type: DRUG

Other Intervention Names

cyclophosphamide, cyclophosphamide, vincristine,prednisone; ifosfamide, carboplatin, etoposide, dexamethasone

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Seog Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won Seog Kim, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center,Seoul,Korea

Locations

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Won Seog Kim, MD,Ph.D.

Role: CONTACT

wskimsmc@skku.edu

234106548 ext. 82

Facility Contacts

Won Seog Kim, M.D, Ph. D

Role: primary

wskimsmc@skku.edu

234106548 ext. 82

Seok Jin Kim, M.D,Ph. D

Role: backup

kstwoh@skku.edu

234101766 ext. 82

Other Identifiers

2014-12-011

Identifier Type: -

Identifier Source: org_study_id