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

Early Phase 1

Completed

• Conditions: Histologically Proven Extranodal NKTcell Lymphoma
• Interventions: Drug: Romidepsin

• Registration Number: NCT01913119
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-29
• Last Update Submitted: 2013-07-29
• Study First Posted: 2013-07-31
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Romidepsin	Romidepsin	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

Primary Outcome Measures

Name	Time	Method
Rate of overall disease control including CR, PR, and SD	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 Outcome Measures

Name	Time	Method
Number of participants with adverse events	from the date of informed consent signature to 30 days after last drug administration	Number of participants with adverse events
Time to progression	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	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.

Trial Locations

Locations (4)

Asan Medical Center; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seodaemun-gu, Seoul, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Korea Cancer Center Hospital; 🇰🇷 Nowon-gu, Seoul, Korea, Republic of