Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma (JAK2)
October 30, 2018 updated by: Won Seog Kim, Samsung Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Busan, Korea, Republic of
- Kosin university gospel hospital
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Busan, Korea, Republic of
- Busan University Hospital
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Busan, Korea, Republic of
- Dong-A University
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Seoul, Korea, Republic of
- Chung-Ang University Hospital
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Seoul, Korea, Republic of, 139-706
- Korean Cancer Center Hospital
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Wonju, Korea, Republic of, 220-701
- Wonju Severance Christian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ruxolitinib
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
|
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
from the date of informed consent signature to 30days after last drug administration
|
|
Overal Survival
Time Frame: from the date of first drug administration until the date of death, assessed up to 48months
|
from the date of first drug administration until the date of death, assessed up to 48months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 15, 2013
Primary Completion (ACTUAL)
June 30, 2017
Study Completion (ACTUAL)
September 18, 2018
Study Registration Dates
First Submitted
October 9, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (ESTIMATE)
October 18, 2013
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 30, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC 2013-06-039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.