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

Phase 2

Completed

• Conditions: Primary Mediastinal Large B-cell Lymphoma; Relapsed or Refractory Hodgkin Lymphoma
• Interventions: Drug: Ruxolitinib

• Registration Number: NCT01965119
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-18
• Study Start: 2013-11-15
• Primary Completion: 2017-06-30
• Study Completion: 2018-09-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)	From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months

Secondary Outcome Measures

Name	Time	Method
Toxicity profile	from the date of informed consent signature to 30days after last drug administration	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.
Overal Survival	from the date of first drug administration until the date of death, assessed up to 48months

Trial Locations

Locations (7)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Dong-A University; 🇰🇷 Busan, Korea, Republic of

Busan University Hospital; 🇰🇷 Busan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korean Cancer Center Hospital; 🇰🇷 Seoul, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of