A Phase 2 interventional study of CHOP and fractionated ICED in Peripheral T-cell Lymphoma, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 134 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes.
Exclusion Criteria:
Other type T-cell lymphoma
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
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
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
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
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
Time frame: 3 years
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
Time frame: 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
Time frame: 3 years
Response duration
Time frame: 3 years
Toxicity profiles
Toxicity profiles as measured by Adverse Events and Laboratory results.
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsung Medical Center