Clinical trial · Interventional
Pilot Study of Ruxolitinib in Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
NCT01965119CI-TRIAL-00035573JAK2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Mediastinal Large B-cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Relapsed or Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ruxolitinib
- description
- 20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
- interventionNames
- Drug: Ruxolitinib
Primary outcomes (1)
- measure
- To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)
- timeFrame
- From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48months
Secondary outcomes (2)
- measure
- Toxicity profile
- timeFrame
- from the date of informed consent signature to 30days after last drug administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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. PMID 31707975