Status:
COMPLETED
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Histologically Proven Extranodal NKTcell Lymphoma
Eligibility:
All Genders
20-79 years
Phase:
EARLY_PHASE1
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 lymph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01913119
Start Date
July 1 2013
End Date
July 1 2013
Last Update
July 31 2013
Active Locations (4)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
2
Korea Cancer Center Hospital
Nowon-gu, Seoul, South Korea, 139-709
3
Severance Hospital
Seodaemun-gu, Seoul, South Korea, 120-752
4
Asan Medical Center
Songpa-gu, Seoul, South Korea, 138-736