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Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma (JAK2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01965119
First received: October 9, 2013
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
The purpose of this study is that ruxolitinib may be a possible treatment option for relapsed or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.

Condition Intervention Phase
Relapsed or Refractory Hodgkin Lymphoma Primary Mediastinal Large B-cell Lymphoma Drug: Ruxolitinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Won Seog Kim, Samsung Medical Center:

Primary Outcome Measures:
  • To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD) [ Time Frame: From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: from the date of informed consent signature to 30days after last drug administration ]
    CTCAE v4 (Common Terminology Criteria for Adverse Events v4.0) In the present study, toxicities will be recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE), version 4.0. The full CTCAE documentation is available on the NCI web site, at the following address: http://ctep.cancer.gov/forms/CTCAEv4.pdf The occurrence of severe adverse event (SAE) should be also reported to the Novartis Safety Office within 24 hours.

  • Overal Survival [ Time Frame: from the date of first drug administration until the date of death, assessed up to 48months ]

Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Drug: Ruxolitinib
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Other Name: jakavi

Detailed Description:
Patients will take ruxolitinib 20 mg orally twice a day, 40mg in total per day, for 4 weeks.4 weeks is 1 cycle. Treatment will be continued until documented disease progression or unacceptable toxicity and the maximum period of treatment is 16 cycles.
  Eligibility

Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven Hodgkin lymphoma or primary mediastinal large B-cell lymphoma
  • Patient should belong to any one of following clinical situations A.Patient who are not able to get autologous stem cell transplantation after relapsing the salvage chemotherapy B. Relapsed after autologous stem cell transplantation C. Refractory to salvage chemotherapy or autologous stem cell transplantation
  • Adequate organ function as defined by the following criteria:

A. 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 B. Total serum bilirubin ≤1.5 x ULN C. Absolute neutrophil count (ANC) ≥ 1500/µL D. Platelets ≥ 100,000/µL E. Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤ 12.0 mg/dL G. Serum creatinine ≤ 1.5 x ULN

  • At least one measurable lesion
  • ECOG PS 0-2
  • Informed consent
  • Age from 19 to 80

Exclusion Criteria:

  • 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.
  • Currently uncontrolled active infection
  • Previous history of recurrent herpes zoster or recurrent tuberculosis
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
  • Pregnant or lactating females or patients who ar not willing to use an adequate method of birth control for the duration of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965119

Locations
Korea, Republic of
Busan University Hospital
Busan, Korea, Republic of
Dong-A University
Busan, Korea, Republic of
Kosin University Gospel Hospital
Busan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korean Cancer Center Hospital
Seoul, Korea, Republic of, 139-706
Chung-Ang University Hospital
Seoul, Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Korea, Republic of, 220-701
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Seog Kim, PhD Samsung Medical Center
  More Information

Responsible Party: Won Seog Kim, M.D., PhD., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01965119     History of Changes
Other Study ID Numbers: SMC 2013-06-039
Study First Received: October 9, 2013
Last Updated: May 16, 2016

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on June 23, 2017