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A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma (Ro-ENKTL)

Primary Purpose

Histologically Proven Extranodal NKTcell Lymphoma

Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Romidepsin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Histologically Proven Extranodal NKTcell Lymphoma focused on measuring extranodal NKTcell lymphoma

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient should belong to any one of following clinical situations

    1. Relapsed after salvage chemotherapy
    2. Relapsed after autologous stem cell transplantation
    3. Refractory to salvage chemotherapy or autologous stem cell transplantation

  2. Adequate organ function as defined by the following criteria:

    1. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
    2. Total serum bilirubin ≤ 1.5 x ULN
    3. Absolute neutrophil count (ANC) ≥1500/µL
    4. Platelets ≥ 75,000/µL
    5. Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
    6. Serum calcium ≤ 12.0 mg/dL
    7. Serum creatinine ≤ 1.5 x ULN
  3. At least one measurable lesion
  4. ECOG PS 0-2
  5. Written informed consent
  6. Over 20 years and under 80 years of age

Exclusion Criteria:

  1. Previously received allogeneic stem cell transplantation
  2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
  4. Pregnancy or breastfeeding.
  5. Any Known cardiac abnormalities
  6. HBV carrier
  7. Positive for HIV

Sites / Locations

  • National Cancer Center
  • Korea Cancer Center Hospital
  • Severance Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Romidepsin

Arm Description

Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity. Dose and administration: 4-hour infusion of 14 mg/m2

Outcomes

Primary Outcome Measures

Rate of overall disease control including CR, PR, and SD
Overall rate of disease control including CR, PR and SD Overall survival: Time between the date of treatment start and the date of death due to any cause

Secondary Outcome Measures

Number of participants with adverse events
Number of participants with adverse events
Time to progression
Performing Cervical, Chest, Abdomen and Pelvis CT scan for the assessment
overall survival
Overall Survival will be measured from the date of first drug administration to the date of death from any cause.

Full Information

First Posted
July 19, 2013
Last Updated
July 29, 2013
Sponsor
Samsung Medical Center
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01913119
Brief Title
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
Acronym
Ro-ENKTL
Official Title
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months. Considering the median number of previous treatments in these patients was three (range 1-11), romidepsin has single agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with salvage treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Histologically Proven Extranodal NKTcell Lymphoma
Keywords
extranodal NKTcell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romidepsin
Arm Type
Experimental
Arm Description
Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity. Dose and administration: 4-hour infusion of 14 mg/m2
Intervention Type
Drug
Intervention Name(s)
Romidepsin
Other Intervention Name(s)
Istodax
Intervention Description
Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity. Dose and administration: 4-hour infusion of 14 mg/m2
Primary Outcome Measure Information:
Title
Rate of overall disease control including CR, PR, and SD
Description
Overall rate of disease control including CR, PR and SD Overall survival: Time between the date of treatment start and the date of death due to any cause
Time Frame
Time between the date of treatment start and the date of death
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Number of participants with adverse events
Time Frame
from the date of informed consent signature to 30 days after last drug administration
Title
Time to progression
Description
Performing Cervical, Chest, Abdomen and Pelvis CT scan for the assessment
Time Frame
from the date of first drug administration until the date of first documented progression
Title
overall survival
Description
Overall Survival will be measured from the date of first drug administration to the date of death from any cause.
Time Frame
from the date of first drug administration until the date of death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient should belong to any one of following clinical situations Relapsed after salvage chemotherapy Relapsed after autologous stem cell transplantation Refractory to salvage chemotherapy or autologous stem cell transplantation Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥1500/µL Platelets ≥ 75,000/µL Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated) Serum calcium ≤ 12.0 mg/dL Serum creatinine ≤ 1.5 x ULN At least one measurable lesion ECOG PS 0-2 Written informed consent Over 20 years and under 80 years of age Exclusion Criteria: Previously received allogeneic stem cell transplantation History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2. Pregnancy or breastfeeding. Any Known cardiac abnormalities HBV carrier Positive for HIV
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Nowon-gu
State/Province
Seoul
ZIP/Postal Code
139-709
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma

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