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

Phase 2CompletedNCT01965119

Samsung Medical Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed or Refractory Hodgkin Lymphoma Primary Mediastinal Large B-cell Lymphoma

Interventions

RuxolitinibDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (7)

Busan University Hospital

Busan, South Korea

Dong-A University

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Asan Medical Center

Seoul, South Korea

Outcomes

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

CTCAE v4 (Common Terminology Criteria for Adverse Events v4.0) In the present study, toxicities will be recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE), version 4.0. The full CTCAE documentation is available on the NCI web site, at the following address: http://ctep.cancer.gov/forms/CTCAEv4.pdf The occurrence of severe adverse event (SAE) should be also reported to the Novartis Safety Office within 24 hours.

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

Data from ClinicalTrials.gov

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