Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma (JAK2)

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Relapsed or Refractory Hodgkin Lymphoma; Primary Mediastinal Large B-cell Lymphoma

Treatments: Drug: Ruxolitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01965119

SMC 2013-06-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ruxolitinib

Experimental group

Description:

20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.

Treatment:

Drug: Ruxolitinib