Clinical trial NCT01965119: Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Official title: Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Refractory Hodgkin Lymphoma
Primary Mediastinal Large B-cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)
timeFrame: From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months
Secondary outcomes:
measure: Toxicity profile
timeFrame: from the date of informed consent signature to 30days after last drug administration
measure: Overal Survival
timeFrame: from the date of first drug administration until the date of death, assessed up to 48months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korean Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SJ, Yoon DH, Kang HJ, Hong JY, Lee HS, Oh SY, Shin HJ, Kong JH, Yi JH, Sakamoto K, Ko YH, Huh J, Lee SS, Takeuchi K, Shin DY, Suh C, Kim WS. Ruxolitinib shows activity against Hodgkin lymphoma but not primary mediastinal large B-cell lymphoma. BMC Cancer. 2019 Nov 10;19(1):1080. doi: 10.1186/s12885-019-6303-z.