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

NCT ID: NCT01913119

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Histologically Proven Extranodal NKTcell Lymphoma

Keywords

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extranodal NKTcell lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Romidepsin

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

Group Type EXPERIMENTAL

Romidepsin

Intervention Type DRUG

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

Interventions

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Romidepsin

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

Other Intervention Names

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Istodax

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Seog Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Korea Cancer Center Hospital

Nowon-gu, Seoul, South Korea

Site Status

Severance Hospital

Seodaemun-gu, Seoul, South Korea

Site Status

Asan Medical Center

Songpa-gu, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-10-059

Identifier Type: -

Identifier Source: org_study_id