RecruitingPhase 2NCT03125642

Auto Stem Cell Transplant for Lymphoma Patients

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


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

150 participants

Start Date

Apr 20, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a stem cell transplant using the patient's own stem cells (called autologous transplant) as a treatment for certain types of lymphoma. **You may be eligible if...** - You have been diagnosed with a type of non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma - Your lymphoma has responded to prior chemotherapy (full or partial remission) - You have had a partial or complete response after CAR-T cell therapy **You may NOT be eligible if...** - Your lymphoma has not responded to chemotherapy (no partial response after up to three cycles of treatment) - You have a type of lymphoma that is excluded by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtoposide

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

DRUGBCNU

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

DRUGAraC

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

DRUGMelphalan

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

PROCEDUREPeripheral 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.

BIOLOGICALG-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

DRUGCyclophosphamide

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

RADIATIONTotal 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

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NCT03125642


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