This trial is active, not recruiting.

Conditions relapsed or refractory hodgkin lymphoma, primary mediastinal large b-cell lymphoma
Treatment ruxolitinib
Phase phase 2
Targets JAK, JAK1, JAK2
Sponsor Samsung Medical Center
Start date November 2013
End date June 2017
Trial size 20 participants
Trial identifier NCT01965119, SMC 2013-06-039


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
ruxolitinib jakavi
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.

Primary Outcomes

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 Outcomes

Toxicity profile
time frame: 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

Eligibility Criteria

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Official title Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Principal investigator Won Seog Kim, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.