Clinical trial NCT01913119: A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
Official title: A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Histologically Proven Extranodal NKTcell Lymphoma
Keywords: extranodal NKTcell lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2013-07-31
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of overall disease control including CR, PR, and SD
timeFrame: Time between the date of treatment start and the date of death
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: from the date of informed consent signature to 30 days after last drug administration
measure: Time to progression
timeFrame: from the date of first drug administration until the date of first documented progression
measure: overall survival
timeFrame: from the date of first drug administration until the date of death
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Nowon-gu
country: Korea, Republic of
facility: Korea Cancer Center Hospital
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
Study officials:
References: