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

Samsung Medical Center

Status and phase: Completed; Early Phase 1

Conditions: Histologically Proven Extranodal NKTcell Lymphoma

Treatments: Drug: Romidepsin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01913119

2012-10-059

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Romidepsin

Experimental group

Description:

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

Treatment:

Drug: Romidepsin