PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Intervention description: Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.
Intervention MeSH terms: Cyclophosphamide; Busulfan; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hodgkin Lymphoma; Non-Hodgkin's Lymphoma; Bone marrow transplant; stem cell transplant; busulfan; cyclophosphamide; etoposide

Summary:

      This is a study for the outcome and safety of individualized busulfan dosing with
      cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat
      Non-Hodgkin or Hodgkin's Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with NHL to be included:

          -  Any subject with NHL that had relapsed or progressed following initial therapy with an
             anthracycline-based chemotherapy regimen and has achieved a subsequent partial
             remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen.

          -  Any subject with NHL that was initially refractory to an anthracycline-based
             chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy
             regimen.

          -  Any subject with an initial International Prognostic Index (IPI) score 4-5 who
             achieved a PR or any CR following an anthracycline-based chemotherapy regimen except
             subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies.

          -  Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR
             or CR after initial therapy.

          -  Any subject that has relapsed or progressed following previous autologous HSCT.

        Subjects with HL to be included:

          -  Any subject with HL that had relapsed or progressed following initial therapy with an
             multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a
             salvage chemotherapy regimen.

          -  Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen
             but who has achieved a PR or CR following a salvage chemotherapy regimen.

          -  Any subject that has relapsed or progressed following previous autologous HSCT.

        Exclusion Criteria:

          -  Any subject with chemoresistant disease by demonstration of less than PR to most
             recent chemotherapy, and any subject with prior treatment history of autologous HSCT
             or high-dose chemotherapy with stem cell rescue for any medical reason will be
             excluded.

        Excluded will also be subjects with existing or active central nervous system lymphoma or
        human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled
        infections.