NCT03125642

Auto Stem Cell Transplant for Lymphoma Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-20
• Primary completion: 2026-09-30
• Completion: 2027-04-30
• First posted: 2017-04-24
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study