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New treatment option for NK-Cell Lymphoma
Official title Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
ClinicalTrials.gov ID: NCT03719105
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, being studied as a potential treatment for nk-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients are in 2 cohorts: Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) . Both groups proceed to allogeneic stem cell transplant with disease response.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 31
You may be able to join if
- Patients must weigh at least 10 kilograms at the time of the study enrollment.
- Diagnosis Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms: COHORT 1
- Aggressive NK cell leukemia (ICD-O code 9948/3)
- Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
- Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
You likely can't join if
- Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
- Patients with active CNS disease.
- Patients with stage I or stage II disease (See Appendix III for Staging).
- Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
- Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received...
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
See the full eligibility criteria
- Patients must weigh at least 10 kilograms at the time of the study enrollment.
- Diagnosis Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms: COHORT 1
- Aggressive NK cell leukemia (ICD-O code 9948/3)
- Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
- Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
- Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
- Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
- Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
- Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for...
- Organ Function Requirements Adequate liver function defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- ALT (SGPT) \< 3 x ULN for age. Adequate cardiac function defined as:
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 50% by radionuclide angiogram. Adequate pulmonary function defined as:
- Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \> 92% while breathing room air unless current...
- Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
- Patients with active CNS disease.
- Patients with stage I or stage II disease (See Appendix III for Staging).
- Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
- Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if...
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
- Lactating females, unless they have agreed not to breastfeed their infants.
- Patients with Down syndrome.
- Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The...
- Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these...
- Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Orange, California, United States
- San Francisco, California, United States
- Grand Rapids, Michigan, United States
- Valhalla, New York, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 31 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Orange, California, United States; San Francisco, California, United States; Grand Rapids, Michigan, United States; Valhalla, New York, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.