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Completed

NCT Number: NCT01965119

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

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.

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Key information

Conditions

Relapsed or Refractory Hodgkin Lymphoma Disease Attributes Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Mediastinal Large B-Cell Lymphoma Recurrence

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Busan University Hospital, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruxolitinib

Drug

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

Other names: jakavi

Primary outcomes

  1. 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 outcomes

  1. Toxicity profile

    Time frame: 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.

  2. Overal Survival

    Time frame: from the date of first drug administration until the date of death, assessed up to 48months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: JAK2

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 18, 2013
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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