Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
Condition: Acute Myeloid Leukemia; Acute Leukemia; Chronic Myelogenous Leukemia; Malignant Lymphoma; Hodgkin's Disease; Multiple Myeloma; Lymphocytic Leukemia; Myeloproliferative Disorder; Polycythemia Vera; Myelofibrosis; Aplastic Anemia
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Polycythemia Vera; Hodgkin Disease; Primary Myelofibrosis; Anemia, Aplastic; Polycythemia; Myeloproliferative Disorders
Study type: Interventional

Summary: 
      New conditioning regimens are still needed to maximize efficacy and limit treatment-related
      deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past
      several years, the investigators have evaluated several new conditioning regimens that
      incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has
      synergistic activity with alkylating agents. Recent data have suggested that fludarabine may
      be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity
      previously observed with cyclophosphamide/ busulfan regimens.
    

Detailed description: 
      Treatment-related mortality and recurrence of disease account for the majority of treatment
      failures in allogeneic transplantation for advanced hematologic malignancies. The most
      commonly utilized conditioning regimens consist of cyclophosphamide and total-body
      irradiation or busulfan and cyclophosphamide. Other agents such as etoposide or thiotepa are
      sometimes added to maximize the antileukemic effect. New conditioning regimens are however
      still needed to maximize efficacy and limit treatment-related deaths. Over the past several
      years, the investigators have evaluated several new conditioning regimens that incorporate
      fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic
      activity with alkylating agents. Recent data have suggested that fludarabine may be used in
      combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously
      observed with cyclophosphamide/ busulfan regimens.
    

Intervention name(s): fludarabine/busulfan; fludarabine/ melphalan; ATG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.; All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).; Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
Other intervention name(s): Fludarabine:; Fludarabine Phosphate; Fludara; Busulfan:; Busulfex; Myleran; Fludarabine:; Fludarabine phosphate; Fludara; Melphalan:; Alkeran; Thymoglobulin
Intervention MeSH terms: Vidarabine; Fludarabine; Fludarabine phosphate; Melphalan; Busulfan; Thymoglobulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; First remission; Acute lymphocytic leukemia; Acute leukemia; Second remission; Early relapse; Partial remission; Accelerated phase; Blast-crisis; Chronic myelogenous leukemia; Chronic phase; Recurrent malignant lymphoma; Refractory malignant lymphoma; Hodgkin's disease; Multiple myeloma.; Chronic lymphocytic leukemia; Myeloproliferative disorder; Polycythemia vera; Myelofibrosis; Severe aplastic anemia