Overview

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

Status:
Completed
Trial end date:
2018-09-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
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