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

NCT02445404

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.

Related Conditions:
  • Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma, ALK-Negative
  • Angioimmunoblastic T-Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Hepatosplenic T-Cell Lymphoma
  • Peripheral T-Cell Lymphoma, NOS
  • Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma
  • Primary Cutaneous Gamma-Delta T-Cell Lymphoma
  • Subcutaneous Panniculitis-Like T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
CHOPcyclophosphamide, cyclophosphamide, vincristine,prednisoneCHOP
fractionated ICEDifosfamide, carboplatin, etoposide, dexamethasoneCHOP

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

NameTypeDescriptionInterventions
CHOPActive Comparatorcyclophosphamide, 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
  • CHOP
  • fractionated ICED
Fractionated ICEDExperimentalifosfamide, 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
  • CHOP
  • fractionated ICED

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

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