Clinical trial · Interventional
Stage I/II Nasal NK Cell Lymphoma
Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
NCT01321008CI-TRIAL-00016793terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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 radiation and chemotherapy will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation + Chemotherapy
- description
- Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
- interventionNames
- Radiation: Radiation
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Day 1 to disease progression or death (up to 5+ years)
- description
- Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma. 2. Adequate blood cell counts (i.e. Absolute neutrophil count (ANC)\> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin. Epoetin will not be administered concurrently with radiation. 3. 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. 4. Patients are required to have adequate renal function as indicated by a serum creatinine \</= 2.5 mg/dL.This value must be obtained within two weeks before protocol entry. 5. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure \>/= 50%. 6. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study. 7. 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). 8. Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry. 9. Patients must have the ability to give informed consent. Exclusion Criteria: 1. Patients with active Hepatitis B and/or Hepatitis C infection. 2. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved. 3. Patients known to be HIV positive. 4. 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 Myocardial infarction (MI) (within 6 months). 5. Patients with prior exposure to anthracyclines: 6. Patients who are pregnant or breast-feeding. 7. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements. 8. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.