Clinical trial NCT01499147
Conditions: Acute Myeloid Leukemia Acute Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Multiple Myeloma Lymphocytic Leukemia Myeloproliferative Disorder Polycythemia Vera Myelofibrosis Aplastic Anemia
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
Sponsor: University of Illinois at Chicago
Start date: 2000-02-01; Completion date: 2013-05-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. arm 2: All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
Interventions: intervention 1: fludarabine/busulfan intervention 2: fludarabine/ melphalan intervention 3: ATG
Intervention descriptions: intervention 1: 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. intervention 2: 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). intervention 3: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.

Protocol documents: