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Non-Hodgkin LymphomaChildren's healthCancerDrugProcedureBiologicalRadiationPhase 2

What this study is

This is a phase II study of autologous transplant for patients with Hodgkin (HL) and non-Hodgkin lymphomas (NHL) including those who are HIV positive.

What's being tested

  • Etoposide

    Intervention · DRUG

    BEAM: 100 mg/m\^2 IV over 2 hours BID on Days -5, -4, -3, -2 | CBV: 150 mg/m\^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4

  • BCNU

    Intervention · DRUG

    BEAM \& CBV: 300 mg/m\^2 IV over over 2 hours on Day -6

  • AraC

    Intervention · DRUG

    BEAM: 100 mg/m\^2 IV over 1 hour BID on Days -5, -4, -3, -2

  • Melphalan

    Intervention · DRUG

    BEAM: 140 mg/m\^2 IV over 20 minutes on Day -1

  • Peripheral blood stem cell transplantation

    Intervention · PROCEDURE

    All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF.

  • G-CSF

    Intervention · BIOLOGICAL

    All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is >2500 x 10\^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm\^3

  • Cyclophosphamide

    Intervention · DRUG

    CBV: 1.5 gm/M\^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 | CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6

  • Total Body Irradiation

    Intervention · RADIATION

    CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

Study details

Official title
Autologous Stem Cell Transplant In Patients With Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)
Sponsor
Masonic Cancer Center, University of Minnesota
Conditions
Non-Hodgkin Lymphoma · Hodgkin Lymphoma
Enrolling
150 people
Starts
2017-04-20
Est. completion
2028-04-30
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗