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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
New York Medical College
Study ID
NCT03719105
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • NK-Cell Leukemia
  • NK-Cell Lymphoma
  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 31 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.
  • pralatraxate, — DRUG
    Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Ifosfamide — DRUG
    Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Dexamethasone — DRUG
    Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Etoposide — DRUG
    Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • calaspargase pegol — DRUG
    Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • cyclophosphamide — DRUG
    Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Doxorubicin — DRUG
    Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Prednisone — DRUG
    Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
  • Brentuximab Vedotin — DRUG
    Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

Study Details

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.

Key Dates

Start date
Mar 1, 2019
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients with aggressive NK cell leukemia or stage III or IV extranodal NK/T-cell lymphoma, nasal type. Chemotherapy Regimen: mSMILE: Methotrexate Day 1, Ifosfamide Days 2-4, Dexamethasone Days 2-4, Etoposide Days 2-4, calaspargase pegol Day 8. For patients in CR and no available allogeneic SCT can receive up to 2 additional cycles of mSMILE. Pembrolizumab: For patients in PR/MR/NR/PD after 2 cycles of mSMILE. Allogeneic Stem Cell Transplant if donor available and not in PD.
  • Experimental: Cohort 2
    Patients with stage III or IV peripheral T-cell lymphoma-NOS, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma (other histologies will be considered after case-by-case discussion with Study Chairs and Executive Vice-Chairs). Chemotherapy Regimen: Cycle 1 \& 2: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 3 \& 5: Brentuximab vedotin Day 1, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 4 \& 6: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Allogeneic Stem Cell Transplant if donor available and not in PD.

Primary Outcome Measure

overall response rate [ Time Frame: 1 year ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35223
Ana Xavier, MD
[email protected]
Children's Hospital Orange CountyOrangeCalifornia92968
Carol Lin, MD
[email protected]
University of California San FranciscoSan FranciscoCalifornia94143
MIchelle Hermiston, MD
[email protected]
Helen De VosGrand RapidsMichigan49503
Troy Quigg, MD
[email protected]
New York Medical CollegeValhallaNew York10595
Mitchell Cairo, MD
[email protected]
914-594-3650
Lauren Harrison, MSN
[email protected]
617-285-7844
Nationwide Children's HospitalColumbusOhio43205
Anthony Audino, MD
[email protected]

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALChildren's Hospital Orange County· Orange, CAUniversity of California San Francisco· San Francisco, CAHelen De Vos· Grand Rapids, MINew York Medical College· Valhalla, NYNationwide Children's Hospital· Columbus, OH

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