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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01965119

Collaborator

(none)

Enrollment

Locations

Arm

58.1

Actual Duration (Months)

2.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Hodgkin Lymphoma Primary Mediastinal Large B-cell Lymphoma	Drug: Ruxolitinib	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2013

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Sep 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.	Drug: Ruxolitinib 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity. Other Names: jakavi

Arm

Intervention/Treatment

Experimental: Ruxolitinib

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

Drug: Ruxolitinib

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

Other Names:

jakavi

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Busan University Hospital	Busan	Korea, Republic of
2	Dong-A University	Busan	Korea, Republic of
3	Kosin University Gospel Hospital	Busan	Korea, Republic of
4	Asan Medical Center	Seoul	Korea, Republic of	138-736
5	Korean Cancer Center Hospital	Seoul	Korea, Republic of	139-706
6	Chung-Ang University Hospital	Seoul	Korea, Republic of
7	Wonju Severance Christian Hospital	Wonju	Korea, Republic of	220-701

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator: Won Seog Kim, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Won Seog Kim, M.D., PhD., Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01965119

Other Study ID Numbers:

SMC 2013-06-039

First Posted:

Oct 18, 2013

Last Update Posted:

Nov 1, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Hodgkin Disease

Study Results

No Results Posted as of Nov 1, 2018