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

Primary Mediastinal Large B-cell Lymphoma Clinical Trial

— JAK2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965119
• Other study ID #: SMC 2013-06-039
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2013
• Est. completion date: September 18, 2018

Study information

• Verified date: October 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 18, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B-cell Lymphoma
• Relapsed or Refractory Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Busan University Hospital	Busan
Korea, Republic of	Dong-A University	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korean Cancer Center Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	from the date of informed consent signature to 30days after last drug administration
Secondary	Overal Survival		from the date of first drug administration until the date of death, assessed up to 48months