Study on Ruxolitinib for Treating Relapsed or Hard-to-Treat T or NK Cell Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
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
| Parameter | Options |
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | Miami | Florida | |
| Northwestern Medicine (Data collection and specimen analysis) | 60611 | Chicago | Illinois |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Weill Cornell Medical College | New York | New York | |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | 11553 | Uniondale | New York |
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