Study on Ruxolitinib for Treating Relapsed or Hard-to-Treat T or NK Cell Lymphoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02974647

This clinical trial is testing the effects of a drug called ruxolitinib on T or NK cell lymphomas that have returned or are difficult to treat. Ruxolitinib works by blocking a protein that helps these cancer cells survive, potentially causing the tumors to shrink.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug ruxolitinib can help shrink T or NK cell lymphomas that have come back or are not responding to other treatments. Ruxolitinib blocks a protein called JAK, which is important for the survival of these cancer cells. By blocking JAK, the drug may help reduce the size of the tumors.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with T or NK cell lymphoma, including stage IB or higher for CTCL.
  • Cancer has returned or not responded after at least one treatment, except for T-PLL where untreated patients may be considered.
  • Age 18 or older.
  • In good general health with an ECOG score of 0 to 2.
  • Have measurable cancer based on specific medical criteria.
  • Stopped previous cancer treatments at least two weeks before starting ruxolitinib.
    • Allowed to use glucocorticoids for symptoms if reduced to 20mg or less by the start of ruxolitinib.
    • Topical steroids for CTCL are allowed.
  • Meet specific blood test criteria:
    • Neutrophil count of at least 1.0/mm³ or 0.5/mm³ if low due to lymphoma.
    • Platelet count of at least 100 x 10⁹/L or 50 x 10⁹/L if low due to lymphoma.
    • Hemoglobin level of at least 8g/dL.
    • Certain liver and kidney function tests within specified limits.
  • If positive for hepatitis B, must have a negative PCR test and take preventive medication.
  • HIV-positive patients are allowed if on treatment and without active infections.

Exclusion Criteria

  • Serious medical or psychiatric conditions that prevent understanding or following the study.
  • Uncontrolled illnesses like active infections, severe diabetes, heart failure, or unstable heart conditions.
  • ECOG score greater than 2.
  • Previous treatment with ruxolitinib.
  • Receiving treatment for another type of cancer, except for T-cell lymphoma.
    • Patients with multiple types of lymphoma may join after discussion with the study leader.
    • Preventive treatments for other cancers are allowed after discussion.
  • Women who can become pregnant must have a negative pregnancy test.
    • Defined as women who have not had surgery to remove reproductive organs or have not been naturally postmenopausal for at least 24 months.

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