Completed

NCT Number: NCT01913119

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

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.

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Key information

Conditions

Histologically Proven Extranodal NKTcell Lymphoma

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romidepsin

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

Other names: Istodax

Primary outcomes

Rate of overall disease control including CR, PR, and SD

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

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 outcomes

Number of participants with adverse events

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

Number of participants with adverse events
Time to progression

Time frame: from the date of first drug administration until the date of first documented progression

Performing Cervical, Chest, Abdomen and Pelvis CT scan for the assessment
overall survival

Time frame: from the date of first drug administration until the date of death

Overall Survival will be measured from the date of first drug administration to the date of death from any cause.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

Celgene Corporation

Registry information

Official study title

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

Acronym: Ro-ENKTL

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 31, 2013
Registry last updated: Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.