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

NCT02445404 | Unknown Phase 2

• 1 other identifier: 2014-12-011
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  3 years

• overall response rate

  3 years

• Response duration

  3 years

• Toxicity profiles

  3 years

Study Arms (2)

CHOP

ACTIVE COMPARATOR

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; Drug: fractionated ICED

Fractionated ICED

EXPERIMENTAL

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; Drug: fractionated ICED

Interventions

CHOP 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

Also known as: cyclophosphamide, cyclophosphamide, vincristine,prednisone

CHOP; Fractionated ICED

fractionated ICED 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

Also known as: ifosfamide, carboplatin, etoposide, dexamethasone

CHOP; Fractionated ICED

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-65 years
• Informed consent
• Subject able to adhere to the study visit schedule and other protocol requirements.
• 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
• Performance status (ECOG) 0,1 or 2
• A negative pregnancy test prior to treatment must be available both for pre-menopausal women

You may not qualify if:

• Other serious medical illnesses or psychiatric disorders
• Any state that the confusion in the interpretation of test result.
• Other type lymphoma ex) B-cell lymphoma
• 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
• Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)
• Previous radiation therapy
• CNS involvement.
• If the contraindication to chemoherapy
• Subject has known historical or active infection with HIV.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Cyclophosphamide; Vincristine; Prednisone; Ifosfamide; Carboplatin; Etoposide; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• Won Seog Kim, MD,Ph.D.

  Samsung Medical Center,Seoul,Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Seog Kim, MD,Ph.D.

CONTACT

234106548; wskimsmc@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 15, 2015
• Study Start: September 23, 2015
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

KR (1)