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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913119
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Won Seog Kim, 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.

Condition or disease Intervention/treatment Phase
Histologically Proven Extranodal NKTcell Lymphoma Drug: Romidepsin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell
Study Start Date : July 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: 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

Drug: 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

Other Name: Istodax




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913119


Locations
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Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Korea Cancer Center Hospital
Nowon-gu, Seoul, Korea, Republic of, 139-709
Severance Hospital
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Samsung Medical Center
Celgene Corporation

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Responsible Party: Won Seog Kim, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01913119    
Other Study ID Numbers: 2012-10-059
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by Won Seog Kim, Samsung Medical Center:
extranodal NKTcell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents