Description:
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.
Title
- Brief Title: Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
- 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 IDs
- ORG STUDY ID:
2014-12-011
- NCT ID:
NCT02445404
Conditions
- Peripheral T-cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| CHOP | cyclophosphamide, cyclophosphamide, vincristine,prednisone | CHOP |
| fractionated ICED | ifosfamide, carboplatin, etoposide, dexamethasone | CHOP |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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 | |
| 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 | |
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
| Maximum Eligible Age: | 65 Years |
| Minimum Eligible Age: | 19 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | progression free survival |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | 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 |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | 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 |
| Measure: | overall response rate |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | 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 |
| Measure: | Response duration |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Toxicity profiles |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | Toxicity profiles as measured by Adverse Events and Laboratory results. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Samsung Medical Center |
Last Updated
October 22, 2020
