Auto Stem Cell Transplant for Lymphoma Patients

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT03125642
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Etoposide — 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 — DRUG
    BEAM \& CBV: 300 mg/m\^2 IV over over 2 hours on Day -6
  • AraC — DRUG
    BEAM: 100 mg/m\^2 IV over 1 hour BID on Days -5, -4, -3, -2
  • Melphalan — DRUG
    BEAM: 140 mg/m\^2 IV over 20 minutes on Day -1
  • Peripheral blood stem cell transplantation — PROCEDURE
    All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF.
  • G-CSF — 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 — 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 — RADIATION
    CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

Study Details

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.

Key Dates

Start date
Apr 20, 2017
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: BEAM: NHL & HL
    BCNU, etoposide, Ara-C and melphalan (BEAM) for all NHL and those HL patients who are unable to receive CBV
  • Experimental: CBV: HL
    Cyclophosphamide, BCNU and VP-16 (CBV) for HL patients
  • Experimental: CY/TBI
    Cyclophosphamide/Total Body Irradiation (CY/TBI) for patients with recent history of CNS lymphoma or those with allergies/contra-indications to agents used in BEAM

Primary Outcome Measure

Progression Free Survival Comparison [ Time Frame: 3 years post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455
Timothy Krepski
[email protected]
612-273-2800
Veronika Bachanova, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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