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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: CHOP; Drug: fractionated ICED

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.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Won Seog Kim, MD,Ph.D.; Phone Number: 82 234106548; Email: wskimsmc@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic Of
    • Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
      • Recruiting
      • Samsung Medical Center
      • Contact: Won Seog Kim, M.D, Ph. D; Phone Number: 82 234106548; Email: wskimsmc@skku.edu
      • Contact: Seok Jin Kim, M.D,Ph. D; Phone Number: 82 234101766; Email: kstwoh@skku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: cyclophosphamide, cyclophosphamide, vincristine,prednisone; 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; Other Names: ifosfamide, carboplatin, etoposide, dexamethasone
Experimental: 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	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; Other Names: cyclophosphamide, cyclophosphamide, vincristine,prednisone; 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; Other Names: ifosfamide, carboplatin, etoposide, dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Response duration		3 years
Toxicity profiles	Toxicity profiles as measured by Adverse Events and Laboratory results.	3 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won Seog Kim, MD,Ph.D., Samsung Medical Center,Seoul,Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2015
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dexamethasone; Cyclophosphamide; Carboplatin; Etoposide; Ifosfamide; Prednisone; Vincristine
• Other Study ID Numbers: 2014-12-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided