40 Participants Needed

Chemoimmunotherapy + Stem Cell Transplant for NK T-cell Lymphoma/Leukemia

Recruiting at 5 trial locations
AX
LH
Overseen ByLauren Harrison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

MC

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

My lymphoma is at an advanced stage (III or IV).
I have been recently diagnosed with a specific type of blood cancer.
Adequate cardiac function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by radionuclide angiogram
See 3 more

Exclusion Criteria

I have only used steroids or radiation in emergencies.
I have an active brain or spinal cord disease.
My condition is ALK positive or negative Anaplastic Large Cell Lymphoma.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemoimmunotherapy

Participants receive induction chemoimmunotherapy with either modified SMILE regimen and pembrolizumab or pralatrexate and brentuximab vedotin, depending on cohort

6 cycles

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

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Brentuximab Vedotin
  • Calaspargase Pegol
  • Cyclophosphamide
  • Dexamethasone
  • Doxorubicin
  • Etoposide
  • Ifosfamide
  • Methotrexate
  • Pralatraxate
  • Prednisone
Trial Overview The study tests two chemoimmunotherapy regimens: modified SMILE plus pembrolizumab (Cohort 1) for NK cell cancers; PRX/BV combined with other drugs (Cohort 2) for peripheral T-cell lymphomas. Successful participants will proceed to allogeneic stem cell transplant.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment5 Interventions
Group II: Cohort 1Experimental Treatment5 Interventions

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Adcetris for:
🇪🇺
Approved in European Union as Adcetris for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York Medical College

Lead Sponsor

Trials
73
Recruited
8,700+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Published Research Related to This Trial

The P-GDP chemotherapy regimen (pegaspargase, gemcitabine, dexamethasone, and cisplatin) demonstrated a high overall response rate of 89.5% in 57 patients with newly diagnosed extranodal NK/T-cell lymphoma, with a complete response rate of 70.2%.
The treatment showed promising safety, with no treatment-related deaths reported, although common severe side effects included neutropenia (42.1%) and thrombocytopenia (38.6%).
Pegaspargase, gemcitabine, dexamethasone, and cisplatin (P-GDP) combined chemotherapy is effective for newly diagnosed extranodal NK/T-cell lymphoma: a retrospective study.Liu, T., Zhu, F., Xiao, Y., et al.[2022]
The SVILE regimen, which includes dexamethasone, vindesine, ifosfamide, pegaspargase, and etoposide, showed a 70% overall response rate and a 45% complete response rate in 20 patients with relapsed/refractory extranodal natural killer/T-cell lymphoma, indicating its effectiveness as a treatment option.
Patients in earlier stages (I/II) had significantly better outcomes, with a 100% complete response rate and three-year progression-free survival of 100%, compared to lower rates in later stages (III/IV), highlighting the importance of early intervention.
SVILE regimen, a combination of dexamethasone, vindesine, ifosfamide, pegaspargase, and etoposide, for treating relapsed/refractory extranodal natural killer/T-cell lymphoma, nasal type.Wei, L., Wang, L., Cong, J., et al.[2020]
In a phase 2 study of 53 patients with stage IV natural killer/T-cell lymphoma, the MEDA chemotherapy regimen resulted in a high overall response rate of 75.5% and a complete response rate of 56.6%, indicating its effectiveness as an induction treatment.
Patients who underwent autologous hematopoietic stem cell transplantation (Auto-HSCT) after achieving complete response had significantly improved long-term survival rates, with a 4-year overall survival rate of 92.0% and progression-free survival rate of 80.0%.
Induction with MEDA regimen and consolidation with Auto-HSCT for stage IV NKTCL patients: A prospective multicenter study.Liu, C., Ding, H., Zhu, Q., et al.[2022]

Citations

Pegaspargase, gemcitabine, dexamethasone, and cisplatin (P-GDP) combined chemotherapy is effective for newly diagnosed extranodal NK/T-cell lymphoma: a retrospective study. [2022]
SVILE regimen, a combination of dexamethasone, vindesine, ifosfamide, pegaspargase, and etoposide, for treating relapsed/refractory extranodal natural killer/T-cell lymphoma, nasal type. [2020]
Induction with MEDA regimen and consolidation with Auto-HSCT for stage IV NKTCL patients: A prospective multicenter study. [2022]
[Comparison of the Effectiveness and Safety of Combined Chemotherapy with PEG-Asp for Treatment of ALL and T-NHL Patients]. [2018]
DDGP followed by radiotherapy vs VIPD followed by radiotherapy in newly diagnosed early NK/T-cell lymphoma. [2022]
Brentuximab vedotin: treatment role for relapsed refractory systemic anaplastic large-cell lymphoma. [2019]
Brentuximab vedotin in relapsed/refractory Hodgkin's lymphoma: the Italian experience and results of its use in daily clinical practice outside clinical trials. [2021]
Experience of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large-cell lymphoma in the Named Patient Program: Review of the literature. [2019]
Risk of adverse events in lymphoma patients treated with brentuximab vedotin: a systematic review and meta-analysis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Brentuximab vedotin. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Nasal NK/T-cell lymphoma with disseminated disease treated with aggressive combined therapy. [2018]
A Prospective Phase II Study of Pegaspargase-COEP Plus Radiotherapy in Patients With Newly Diagnosed Extra-Nodal NK/T-Cell Lymphoma. [2022]
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