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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Hodgkin Lymphoma

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

  • Busan University Hospital
  • Dong-A University
  • Kosin University Gospel Hospital
  • Asan Medical Center
  • Korean Cancer Center Hospital
  • Chung-Ang University Hospital
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib

Arm Description

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

Outcomes

Primary Outcome Measures

To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)

Secondary Outcome Measures

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.
Overal Survival

Full Information

First Posted
October 9, 2013
Last Updated
October 30, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01965119
Brief Title
Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Acronym
JAK2
Official Title
Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2013 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
September 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hodgkin Lymphoma, Primary Mediastinal Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
jakavi
Intervention Description
20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Toxicity profile
Description
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
Title
Overal Survival
Time Frame
from the date of first drug administration until the date of death, assessed up to 48months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Busan University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Dong-A University
City
Busan
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korean Cancer Center Hospital
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31707975
Citation
Kim SJ, Yoon DH, Kang HJ, Hong JY, Lee HS, Oh SY, Shin HJ, Kong JH, Yi JH, Sakamoto K, Ko YH, Huh J, Lee SS, Takeuchi K, Shin DY, Suh C, Kim WS. Ruxolitinib shows activity against Hodgkin lymphoma but not primary mediastinal large B-cell lymphoma. BMC Cancer. 2019 Nov 10;19(1):1080. doi: 10.1186/s12885-019-6303-z.
Results Reference
derived

Learn more about this trial

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

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