Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation
Condition: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)
      followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine
      in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.
    

Detailed description: 
      This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a
      conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe
      and helps patients with Non-Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC
      transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a
      conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a strong
      drug that suppresses the immune system and fludarabine is a chemotherapy (cancer fighting)
      drug. These drugs can stop the growth of cancer cells by breaking the Deoxyribonucleic acid
      (DNA) or genetic material which is necessary for the growth of both healthy and cancer cells.
      The use of IV busulfan with fludarabine as a conditioning regimen prior to HPC transplant is
      investigational (not approved by the Food and Drug Administration [FDA]).

      Busulfan is only given once daily by IV in this study, which is also not approved by the FDA.
      Patients in this study will go through standard procedures for their disease like medical
      history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or
      echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be
      asked to donate additional blood and bone marrow for this study and for potential future
      research on their blood related to this study. Because of the normal procedures for HPC
      transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will
      make frequent trips to the clinic to visit the study doctor for supervision for at least one
      year. Each patient will also have to have a central venous catheter inserted into a large
      vein above the heart. This is used to give the drugs and to take blood samples.

      Participation in this study will last about two years. The study expects to enroll 32
      patients and will open to at least two collaborating institutions in the future. Upon initial
      Institutional Review Board (IRB) approval enrollment will only occur at West Virginia
      University (WVU). The IRB will be notified before enrollment occurs at other institutions.
    

Intervention name(s): Busulfan; Fludarabine
Intervention type(s): Drug; Drug
Intervention description(s): Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6; Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Other intervention name(s): Busulfex; Fludarabine Monophosphate; Fludara
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin's; non-Hodgkin's; lymphomas; allogeneic hematopoietic progenitor cell transplant; HPCT; busulfex; fludarabine; reduced-toxicity conditioning; reduced-intensity conditioning