Clinical trial NCT02445404: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: overall response rate
timeFrame: 3 years
measure: Response duration
timeFrame: 3 years
measure: Toxicity profiles
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul, Korea, Republic Of
Study officials:
affiliation: Samsung Medical Center,Seoul,Korea
name: Won Seog Kim, MD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: