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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan University Hospital | Busan | South Korea | ||||
| Dong-A University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31707975 | Derived | 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. |
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| from the date of informed consent signature to 30days after last drug administration |
| Overal Survival | from the date of first drug administration until the date of death, assessed up to 48months |
| Busan |
| South Korea |
| Kosin University Gospel Hospital | Busan | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Korean Cancer Center Hospital | Seoul | 139-706 | South Korea |
| Chung-Ang University Hospital | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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