Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsed or Refractory Hodgkin Lymphoma; Primary Mediastinal Large B-cell Lymphoma
Intervention: Ruxolitinib (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s): Won Seog Kim, PhD, Principal Investigator, Affiliation: Samsung Medical Center
Overall contact: Won Seog Kim, PhD, Phone: 82-2-3410-6548, Email: wonseog.kim@samsung.com
Summary
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.
Clinical Details
Official title: Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)
Secondary outcome: Toxicity profileOveral Survival
Eligibility
Minimum age: 19 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Won Seog Kim, PhD, Phone: 82-2-3410-6548, Email: wonseog.kim@samsung.com
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting Dok Hyun Yoon, PH, Phone: 82-10-3235-3090, Email: dhyoon@amc.seoul.kr Duk Hyun Yoon, PhD., Principal Investigator
Ehwa Womens University Hospital, Seoul 158-710, Korea, Republic of; Not yet recruiting Young Chul Moon, Email: yeungchul@ewha.ac.kr Young Chul Moon, Principal Investigator
Hanyang University Hospital, Seoul 133-792, Korea, Republic of; Not yet recruiting Byeong-Bae Park, Email: drbbpark@gmail.com Byeong-Bae Park, Principal Investigator
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of; Not yet recruiting Yong Park, Email: paark76@hanmail.net Yong Park, Principal Investigator
Korean Cancer Center Hospital, Seoul 139-706, Korea, Republic of; Recruiting Hye Jin Kang, Phone: 82-10-2980-9262, Email: hyejin@kcch.re.kr Hye Jin Kang, Principal Investigator
Yonsei Medical Center, Seoul 120-752, Korea, Republic of; Recruiting Jin Seok Kim, Phone: 82-2-2228-1972, Email: hemakim@yuhs.ac Jin Seok Kim, Principal Investigator
Chonnam University Hwasoon Hospital, Hwasun, Jeollanam-do 519-763, Korea, Republic of; Not yet recruiting Deok-Hwan Yang, Email: drydh1685@hotmail.com Deok-Hwan Yang, Principal Investigator
Ajou University Hospital, Suwon, Kyunggi-do 443-721, Korea, Republic of; Not yet recruiting Seong Hyun Jeong, Email: seonghyunmd@naver.com Seong Hyun Jeong, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: June 15, 2014
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