Health TrialsbyHealthPanel

Auto Stem Cell Transplant for Lymphoma Patients

ConditionsNon-Hodgkin LymphomaHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 75
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Eligible Diseases

Non-Hodgkin's Lymphoma (NHL)

Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification.

Patients in partial or complete remission following cell therapy will also be eligible.

Disqualifiers

Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy

Eligible for any higher priority transplant protocols

Chemotherapy resistant disease

Unrelated active infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

  • G-CSF

    Biological/Vaccine

    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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: BEAM: NHL & HLExperimental treatment 6 interventions
Group B: CBV: HLExperimental treatment 3 interventions
Group C: CY/TBIExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival Comparison

Compare progression-free survival (PFS) at 3 years post-transplant for patients who received who received a radiation free preparative regimen to the prior study MT2004-24 where NHL subjects received total body irradiation (TBI) as part of their preparative regimen.

Time frame
3 years post transplant

Secondary outcomes

1

Overall Survival

Incidence of survival

Time frame
3 years post transplant
2

Treatment related mortality

Incidence of treatment related mortality

Time frame
6 months post transplant
3

Treatment related mortality

Incidence of treatment related mortality

Time frame
1 year post transplant
4

Secondary malignancies

Cumulative incidence of secondary malignancies

Time frame
3 years post transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
Apply now