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

Primary Purpose

Peripheral T-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CHOP
fractionated ICED
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHOP

Fractionated ICED

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Response duration
Toxicity profiles
Toxicity profiles as measured by Adverse Events and Laboratory results.

Full Information

First Posted
May 12, 2015
Last Updated
October 21, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02445404
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2015 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHOP
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fractionated ICED
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CHOP
Other Intervention Name(s)
cyclophosphamide, cyclophosphamide, vincristine,prednisone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
fractionated ICED
Other Intervention Name(s)
ifosfamide, carboplatin, etoposide, dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
progression free survival
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
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
Time Frame
3 years
Title
overall response rate
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
Time Frame
3 years
Title
Response duration
Time Frame
3 years
Title
Toxicity profiles
Description
Toxicity profiles as measured by Adverse Events and Laboratory results.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. life expectancy≥90day(3months) Exclusion Criteria: 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. 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 serum creatinine level > 2.0 x ULN Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri MUGA scan <45% Those who administered doxorubicin exceeding 200 mg / m2 Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. Breast-feeding or pregnant female
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Seog Kim, MD,Ph.D.
Phone
234106548
Ext
82
Email
wskimsmc@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, MD,Ph.D.
Organizational Affiliation
Samsung Medical Center,Seoul,Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul, Korea, Republic Of
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, M.D, Ph. D
Phone
234106548
Ext
82
Email
wskimsmc@skku.edu
First Name & Middle Initial & Last Name & Degree
Seok Jin Kim, M.D,Ph. D
Phone
234101766
Ext
82
Email
kstwoh@skku.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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