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

Early Phase 1CompletedNCT01913119

Samsung Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Histologically Proven Extranodal NKTcell Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (4)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Korea Cancer Center Hospital

Nowon-gu, Seoul, South Korea

Severance Hospital

Seodaemun-gu, Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: Time between the date of treatment start and the date of death

Secondary Outcomes

Number of participants with adverse events

Time frame: from the date of informed consent signature to 30 days after last drug administration

Time to progression

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

overall survival

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