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Auto Stem Cell Transplant for Lymphoma Patients

NCT03125642 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-04

No results posted yet for this study

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

Interventions

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

DRUG

Melphalan

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

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

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Veronika Bachanova, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2026-09-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125642 on ClinicalTrials.gov