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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445404
• Other study ID #: 2014-12-011
• Status: Recruiting
• Phase: Phase 2
• Start date: September 23, 2015
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: Won Seog Kim, MD,Ph.D.
• Phone: 234106548
• Email: wskimsmc[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Seoul, Korea, Republic Of

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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