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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 profile

Overal 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

Page last updated: August 23, 2015

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