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RECRUITING
NCT03125642
PHASE2

Auto Stem Cell Transplant for Lymphoma Patients

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

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.

Official title: Autologous Stem Cell Transplant In Patients With Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

Key Details

Gender

All

Age Range

Any - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2017-04-20

Completion Date

2027-04-30

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

DRUG

Etoposide

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

DRUG

BCNU

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

DRUG

AraC

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

DRUG

Melphalan

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

PROCEDURE

Peripheral blood stem cell transplantation

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

BIOLOGICAL

G-CSF

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

DRUG

Cyclophosphamide

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

RADIATION

Total Body Irradiation

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

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States