Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma (NCT02106988) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma
United States26 participantsStarted 2015-01-16
Plain-language summary
The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied.
This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with newly diagnosed stage I and II nasal NK cell lymphoma.
. Adequate blood cell counts (i.e. ANC \> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.
. Patients must have adequate liver function as indicated by: \*Bilirubin \</= 1.5 times the upper limit of normal (ULN), \* Alanine transaminase (ALT) \</= 2 times the (ULN) or aspartate transaminase (AST) \</= 2 times the ULN, \*These values must be obtained within two weeks before protocol entry.
. Patients are required to have a serum creatinine \</= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry.
. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure \>/= 50%.
. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From registration to disease progression or death due to disease, up to 5 years
. Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses \> two years or surgically sterilized).
. Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.
Exclusion criteria
. Patients with active Hepatitis B and/or Hepatitis C infection.
. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
. Patients known to be HIV positive.
. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV CHF per new york heart association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent MI (within 6 months).
. Patients who are pregnant or breast-feeding.
. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
. Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.