Chemoimmunotherapy + Stem Cell Transplant for NK T-cell Lymphoma/Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are in Cohort 2 and taking medications that affect CYP3A4, you may need to stop them before joining the trial. Specifically, you should not take CYP3A4 inhibitors within 7 days or CYP3A4 inducers within 12 days before enrolling. The trial does not specify other medication restrictions.
What safety data exists for Brentuximab Vedotin in humans?
Brentuximab Vedotin has been shown to be generally safe in humans, but it can cause side effects like peripheral neuropathy (nerve damage causing tingling or numbness), fatigue, nausea, and fever. Serious side effects, though rare, include severe nerve damage and blood-related issues, and it carries a warning for a rare brain infection. Overall, it is considered to have a manageable safety profile in treating certain types of lymphoma.12345
What makes the chemoimmunotherapy and stem cell transplant treatment for NK T-cell lymphoma/leukemia unique?
This treatment is unique because it combines chemoimmunotherapy with a stem cell transplant, using a mix of drugs like Brentuximab Vedotin and Calaspargase Pegol, which are not typically used together in standard treatments for NK T-cell lymphoma/leukemia. This combination aims to enhance the immune response and improve outcomes for patients with this rare and aggressive cancer.678910
What data supports the effectiveness of the treatment for NK T-cell Lymphoma/Leukemia?
Research shows that treatments involving components like pegaspargase, dexamethasone, and etoposide have been effective in treating NK/T-cell lymphoma. For example, a study using the MEDA regimen (which includes methotrexate, etoposide, dexamethasone, and pegaspargase) showed a high response rate and improved long-term survival when followed by stem cell transplantation.6891112
Who Is on the Research Team?
Mitchell Cairo, MD
Principal Investigator
New York Medical College
Are You a Good Fit for This Trial?
This trial is for children, adolescents, and young adults with advanced T-cell or NK-cell leukemia/lymphoma. They must weigh at least 10 kg, have good heart and lung function, and not be pregnant or breastfeeding. Prior chemotherapy for the current diagnosis disqualifies participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemoimmunotherapy
Participants receive induction chemoimmunotherapy with either modified SMILE regimen and pembrolizumab or pralatrexate and brentuximab vedotin, depending on cohort
Allogeneic Stem Cell Transplant
Participants proceed to allogeneic stem cell transplant if a donor is available and they are not in progressive disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brentuximab Vedotin
- Calaspargase Pegol
- Cyclophosphamide
- Dexamethasone
- Doxorubicin
- Etoposide
- Ifosfamide
- Methotrexate
- Pralatraxate
- Prednisone
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York Medical College
Lead Sponsor
University of Alabama at Birmingham
Collaborator